BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3250854 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-11970
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (REPORTER AND PATIENT BEING UNAWARE OF THIS ADVANCED FEATURE PROGRAMMED BY THE HEALTH CARE PROVIDER).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/27/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/05/2016 WITH THE FOLLOWING FINDINGS: THE BB STARTS ON (B)(6) 2016. UNABLE TO VERY AUTO OFF ALARM AND LOSS OR PRIME ON EVENT DATE (B)(6) 2013 DUE TO OVERWRITTEN DATA IN THE BLACK BOX DATA AND HISTORIES. A 24 HR DURATION TEST WAS SUCCESSFULLY COMPLETED WITH NO LOSS OF PRIME WARNINGS BEING DUPLICATED. THE PUMP IS DETECTING THE CORRECT FORCE. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP GAVE A PUMP NOT PRIMED WARNING. THE REPORTER STATED THAT THE PATIENT WAS DISCONNECTED FROM THE SKIN SITE AND PRIMED PUMP. THE REPORTER STATED THAT THEY DID SKIP THE FILL CANNULA STEP. CUSTOMER SUPPORT (CS) REVIEWED ALARM HISTORY AND AUTO OFF OCCURRED ABOUT HOUR AGO. CS EXPLAINED THE AUTO OFF FEATURE AND WALKED THROUGH THE PUMP SETTINGS TO EXPLAIN THAT IT IS SET TO 14 HOURS. THE REPORTER STATED THAT THE PATIENT DID NOT BOLUS FOR BREAKFAST AND BLOOD GLUCOSE (BG) WAS READING HIGH ON THE METER. THE REPORTER WAS TO CALL THEIR HEALTHCARE PROFESSIONAL FOR GUIDELINES ON BOLUSING OR MANUAL INJECTION. THIS REPORT IS BEING MADE DUE TO THE PATIENT¿S ALLEGED HYPERGLYCEMIC EVENT THAT RESULTED FROM THE REPORTER AND PATIENT BEING UNAWARE OF THIS ADVANCED FEATURE PROGRAMMED BY THE HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353353 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening