BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3871647 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16783
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    June 8, 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

    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

    (B)(4). DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA SHOWED EVIDENCE OF SHORT BATTERY LIFE, WITH MULTIPLE LOW AND REPLACE BATTERY WARNINGS. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP WITH THE VIBRATORY FEATURE BUT NO AUDIBLE ALERT. THE KEYPAD BUTTONS RESPONDED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE WAS EXECUTED WITHOUT INCIDENTS. THE ELECTRICAL CURRENT DRAWS WERE HIGH OUT OF SPECIFICATIONS. THE PUMP CASING WAS OPENED AND EVIDENCE OF MOISTURE CORROSION WAS OBSERVED ON THE SOUND DRIVE CIRCUIT AND INSIDE THE PUMP. THE REPORTED SHORT BATTERY LIFE WAS VERIFIED IN THE BLACK BOX AND CONFIRMED IN THE INVESTIGATION. UNRELATED TO THE POWER ISSUE, THE DISPLAY WAS DIM AND DISCOLORED, AND THE BOLUS BUTTON COVER WAS TORN.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. REPORTEDLY, THE BATTERY LIFE WAS LESS THAN EXPECTED AND ALARM HISTORY SHOWED RECURRING LOW BATTERY WARNINGS. IT WAS REPORTED THAT 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
    350558 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR