BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3912448 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19044
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED A 128-FE88 REPLACE BATTERY ALARM THAT WAS EMITTED A DAY AFTER A BATTERY CHANGE DUE TO A 5 VOLT POWER SUPPLY REWIND FAULT. DURING A VISUAL INSPECTION OF THE PUMP, NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT OR RETURNED BATTERY CAP. THE RETURNED BATTERY CAP SECURED PROPERLY TO THE PUMP. THE BOLUS BUTTON COVER WAS OBSERVED TO BE MISSING, AND EVIDENCE OF MOISTURE INGRESS WAS FOUND ON THE UNDERSIDE OF THE BATTERY CAP. CURRENT DRAWS MEASURED WITHIN SPECIFICATIONS. A LEAK TEST WAS PERFORMED AND CONFIRMED A BOLUS BUTTON LEAK. THE PUMP CASE WAS REMOVED, AND FURTHER EVIDENCE OF MOISTURE INGRESS WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE WITH DAMAGE/MOIST) ISSUE. IT WAS ALLEGED THAT THERE WAS EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT AND THE BATTERY COMPARTMENT WAS CRACKED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391337 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR