BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3954645 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21227
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    FOLLOW-UP #1 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/20/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND ONE LOW BATTERY WARNING DUE TO NORMAL BATTERY WEAR, NO EVIDENCE OF SHORT BATTERY LIFE WAS OBSERVED. THE PUMP POWERED UP TO THE VERIFY SCREEN WITH AUDITORY AND VIBRATORY FEATURES. ALL THE BUTTONS RESPONDED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENCES. THE ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE REPORTED BATTERY LIFE ISSUE WAS NOT VERIFIED IN THE BLACK BOX OR DUPLICATED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE BATTERY LIFE WAS LESS THAN EXPECTED. REPORTEDLY, THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. THE ISSUE ALLEGEDLY HAD OCCURRED WITH MULTIPLE BATTERIES FROM DIFFERENT PACKS. 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
    433723 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR