BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3943234 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20528
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 08/27/2014. DEVICE EVALUATION: THE 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. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED FROM THE OPENING TO THE BASE SEAL. THERE WAS NO EVIDENCE OF MOISTURE INGRESS INSIDE THE COMPARTMENT. THE REPORTED CASING ISSUE WAS CONFIRMED BY THE INVESTIGATION. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. ALL THE KEYPAD BUTTONS RESPONDED PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. REPORTEDLY, THE BATTERY COMPARTMENT WAS CRACKED/DAMAGED. IT WAS REPORTED THAT THE BATTERY CAP WAS UNDAMAGED AND THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION IN THE PUMP. 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
    422050 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR