BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4864459 · Received June 23, 2015

    Report

    Report Number
    2531779-2015-20828
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    June 8, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: - DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/29/2015 WITH THE FOLLOWING FINDINGS: THE PUMP'S BLACK BOX SHOWED EVIDENCE OF SHORT BATTERY LIFE ALONG WITH VOLTAGE DROPS AND BATTERY ALARMS. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE BATTERY COMPARTMENT. THE PUMP'S CURRENT DRAWS WERE WITHIN SPECIFICATIONS. A BATTERY LIFE ISSUE WAS NOT DUPLICATED DURING THE INVESTIGATION. THE PUMP PASSED A LEAK TEST. THERE WAS NO EVIDENCE OF ADDITIONAL MOISTURE OR LOOSE COMPONENTS INSIDE PUMP.

    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 THAT THE PUMP HAD 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
    406316 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR