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4.50: Glucosemeter Recall

  • Page ID
    123354
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    A nurse manager is told by one of the clinic nurses that sometimes an icon, which reads “temp”, has appeared on one of the new glucose meters. The nurse manager calls the Chemistry laboratory’s POCT supervisor. The nurse states that the meter is being used, as usual, at room temperature. The nurse did not hold it in her hand long enough for the meter to warm up and, as far as she knows, it was not placed on ice or in a refrigerator. The presence of icons was not discussed in training. The icon has disappeared and has not been seen again in the last day or so. The POCT supervisor’s initial reaction is to tell the nurse manager that if the icon does not appear again, she can ignore the incident.

    The POCT supervisor then discusses this with the Lab’s technical supervisor. They agree on another course of action.

    QUESTIONS

    1. What might the new course of action be?
    2. The POCT supervisor calls the instrument manufacturer to determine what are the implications of this icon, that is, does it indicate a problem that will affect the test results? Also have any other complaints about this icon been made to the company? The POCT supervisor is told that the icon indicates temperature problems within the meter and may affect the results. She is informed the problem seems to occur in a small number of cases and that all meters with this icon will be replaced. The company is investigating this and other complaints further. What should the supervisor’s response be now?

    Question to Consider

    1. What are the recommended responses when irresolvable instrumentation problems are encountered?
    2. Should a backup plan exist for instrument downtime?
    Answer
    1. The lab Director and the supervisor read the detailed device product description to find the meaning of the icon. Unsatisfied with the information provided, they place a high priority call to the manufacturer’s customer service department for assistance. 344A backup plan for instrument downtime must be written for every instrument (see QC chapter, pp 394-395), including POCT instruments. The plan should indicate WHEN an instrument or test is determined to be not usable and WHAT is the alternative testing procedure.

      The immediate response should be to find out how widespread the icon problem is in the institution, that is,how many meters are affected, and to have the affected meters removed from service and replaced if possible by non-affected meters. If non-affected meters are not available, then the central laboratory must be used for the testing. In addition, the laboratory staff must educate nurses and others using instrument about the meaning of the icon.
    2. Instruments with the icon problem are removed from service. However, some are kept in critical areas because of the demonstrated need to maintain this testing. Nurses are asked NOT to respond to any result with the icon, but instead send a sample to the central laboratory for analysis.

    Answers to Questions to Consider

    1. The recommended laboratory response (see p 394) to an unsolvable instrument failure includes the following sequential steps: reading the product information, calling the manufacturer’s ‘hot line’ or technical staff for additional help, and requesting manufacturer service.
    2. The nurses and physicians in the critical care areas are told that because of the imprecision associated with the affected meters, ANY result within \(\pm\)25% of a value that might require patient intervention, especially the introduction of insulin, must be verified in the central laboratory, preferably by glucose analyses performed on the Stat. blood-gas instruments. Another valid option would be to immediately remove the meters and procede with plans to replace them with another brand.

    This page titled 4.50: Glucosemeter Recall is shared under a CC BY-NC-SA 4.0 license and was authored, remixed, and/or curated by Lawrence Kaplan & Amadeo Pesce.

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