BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4191373 · Received October 21, 2014

    Report

    Report Number
    2531779-2014-29866
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/01/2014 WITH THE FOLLOWING FINDINGS: THE PUMP'S BLACK BOX SHOWED NO EVIDENCE OF SHORT BATTERY LIFE. THE BLACK BOX RECORDINGS INDICATE THAT THE REPLACEMENT BATTERIES USED WERE NOT FULLY CHARGED. THERE WERE SEVERAL LOW BATTERY WARNINGS DUE NORMAL BATTERY WEAR OBSERVED. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE CASE SEAL. ALL OF THE PUMP'S CURRENT DRAWS WERE WITHIN SPECIFICATIONS. THE ALLEGED ISSUE COULD NOT BE DUPLICATED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP WAS EXPERIENCING SHORTER THAN EXPECTED BATTERY LIFE. 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
    669374 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR