BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4841897 · Received June 12, 2015

    Report

    Report Number
    2531779-2015-19660
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 31, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/29/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/13/2015 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY WAS REVIEWED AND NO EVIDENCE OF BATTERY LIFE ISSUE WAS OBSERVED. BATTERY VOLTAGES IN THE BLACK BOX ARE WITHIN NORMAL SPECIFICATIONS. PUMP CURRENT DRAWS ALL MEASURED WITHIN SPECIFICATION. INVESTIGATORS REMOVED THE PUMP COVER AND NO INTERMITTENT CONNECTIONS OR MOISTURE DAMAGE WAS OBSERVED. INVESTIGATORS WERE UNABLE TO DUPLICATE COMPLIANT. THE DISPLAY SCREEN HAS A PINKISH CONTRAST. BATTERY COMPARTMENT IS CRACKED BELOW THE BUMPER PAD.

    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) 2015, 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
    385610 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR