BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4210451 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30767
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 INSULIN PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA DID NOT FIND EVIDENCE OF SHORT BATTERY LIFE. THE RETURNED CAPS WERE USED TO COMPLETE THE EVALUATION. THE PUMP POWERED ON WITH AUDITORY AND VIBRATORY FEATURES. ALL THE BUTTONS RESPONDED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE WAS COMPLETED WITHOUT INCIDENCES. THE ELECTRICAL CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE REPORTED BATTERY LIFE ISSUE WAS NOT VERIFIED IN THE BLACK BOX OR DUPLICATED IN THE INVESTIGATION. UNRELATED TO THE REPORTED BATTERY LIFE ISSUE, IT WAS OBSERVED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED BELOW THE GRIP PAD.

    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. 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
    692503 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR