BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3940252 · Received July 17, 2014

    Report

    Report Number
    2531779-2014-20383
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    July 8, 2014
    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

    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 09/10/2014 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED EVIDENCE OF POWER REBOOTS OCCURRING. VISUAL INSPECTION REVEALED THAT THERE WERE BATTERY COMPARTMENT CRACKS IN THE THREAD AREA AND BELOW THE GRIP PAD. DURING TESTING, THE PUMP POWERED ON APPROPRIATELY WITH THE RETURNED BATTERY CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER REBOOTS, POWER LOSSES, OR CALL SERVICE ALARMS OCCURRING. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. THE COMPLAINT THAT THE PUMP HAD NO POWER WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. IT WAS REPORTED THAT THE PUMP HAD NO POWER. IT WAS NOTED THAT THE POWER ISSUE OCCURRED DURING OR IMMEDIATELY AFTER A BATTERY CHANGE. 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
    418137 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR