BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3874400 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17093
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 05/13/2015-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 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. A REVIEW OF THE PUMP BLACK BOX DATA REVEALED THAT INFORMATION FROM THE EVENT DATE HAD BEEN OVERWRITTEN DUE TO CONTINUED USE. DURING A VISUAL INSPECTION OF THE PUMP, THE BATTERY COMPARTMENT WAS OBSERVED TO BE INTACT WITH NO DAMAGE OR EVIDENCE OF MOISTURE INGRESS. THE BATTERY CAP SECURED PROPERLY TO THE PUMP, AND A POWER LOSS WAS NOT OBSERVED. CURRENT DRAWS MEASURED WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE INGRESS OR LOOSE COMPONENTS WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. IT WAS REPORTED THAT THE PUMP BATTERY LIFE DID NOT LAST AS LONG AS EXPECTED. MULTIPLE BATTERIES FROM DIFFERENT PACKAGES WERE USED IN THE PUMP; HOWEVER, THE ISSUE OF SHORT BATTERY LIFE RECURRED. 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
    353401 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR