BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3842068 · Received May 31, 2014

    Report

    Report Number
    2531779-2014-15269
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Report Date
    May 27, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: MULTIPLE LOW BATTERY WARNINGS WERE OBSERVED IN THE ALARM HISTORY DATA; THE FREQUENCY OF LOW BATTERY WARNINGS AS OBSERVED IN THE ALARM HISTORY DATA WAS NOT DUPLICATED. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, WHICH WAS ABLE TO FULLY TIGHTEN TO THE PUMP. EVALUATION REVEALED THAT THE PUMP DREW ELECTRICAL CURRENT WITHIN THE SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE INGRESS OR LOOSE INTERNAL COMPONENTS WAS OBSERVED. UNRELATED TO THIS COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. 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
    320426 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR