BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3973317 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22084
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 - DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/13/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED MULTIPLE UNEXPLAINED PUMP REBOOTS. DURING TESTING, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE RETURNED BATTERY CAP HAD STRIPPED THREADS, AND WAS UNABLE TO FULLY SECURE ONTO THE PUMP. THE UNEXPLAINED PUMP REBOOTS WERE DUPLICATED WITH THE RETURNED BATTERY CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH A TEST BATTERY CAP, AND NO POWER INTERRUPTIONS OR DUPLICATED ALARMS WERE OBSERVED. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE WAS FOUND INSIDE THE PUMP. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN WAS DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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
    450982 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR