BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3834414 · Received May 28, 2014

    Report

    Report Number
    2531779-2014-14991
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING RESULTS: A REVIEW OF THE BLACK BOX SHOWED ONE LOW BATTERY WARNING. EVIDENCE OF SHORT BATTERY LIFE WAS OBSERVED. MULTIPLE LOW BATTERY WARNINGS AND REPLACE BATTERY ALARMS WERE OBSERVED IN THE ALARM HISTORY. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AND THE BATTERY CAP HAD DAMAGED THREADS. EVIDENCE OF MOISTURE CORROSION WAS OBSERVED IN THE BATTERY COMPARTMENT. THE CAP WAS UNABLE TO FULLY TIGHTEN ON TO THE PUMP; HOWEVER, NO POWER LOSS WAS OBSERVED. THE PUMP¿S CURRENT DRAWS WERE FOUND TO BE WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE AUDIO BOLUS BUTTON COVER WAS TORN AND THE PUMP FAILED A LEAK TEST DUE TO THIS. THE PUMP COVER WAS OPENED AND EVIDENCE OF INTERNAL MOISTURE WAS FOUND INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BATTERY LIFE ISSUE AND A CRACKED BATTERY COMPARTMENT. 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
    314311 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR