BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4007682 · Received August 13, 2014

    Report

    Report Number
    2531779-2014-23336
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Report Date
    August 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 02/26/2015-PRODUCT ANALYSIS:THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/11/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT WAS UNABLE TO BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE BLACK BOX REVEALED NO RELATED ALARMS OR ISSUES; DATA RELEVANT TO THE COMPLAINT WAS OVERWRITTEN DUE TO EXTENDED PUMP USE. THE TOTAL DAILY DOSE HISTORY CORRECTLY REFLECTS THE USER PROGRAMMED BASAL RATES. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP PASSED A DELIVERY ACCURACY TEST. UNRELATED TO THE COMPLAINT, A BATTERY COMPARTMENT CRACK WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING AN INACCURATE DELIVERY ISSUE. IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 250-499 MG/DL WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTER NOTED THE BASAL DELIVERY TOTALS IN TOTAL DAILY DOSE MATCH ACTIVE BASAL PROGRAM TOTAL AND THE BOLUS HISTORY AND BOLUSES RECORDED IN THE TOTAL DAILY DOSE HISTORY MATCH. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS HEALTH CONDITION IS NOT CONSIDERED A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482648 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR