BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3822396 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14288
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/10/2014 - 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 NO EVIDENCE OF POWER REBOOTS WAS RECORDED. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE THREADS TO THE CASE SEAL. THE BATTERY CAP WAS NOT ABLE TO BE FULLY SECURED TO THE PUMP. THE BATTERY CAP THREADS WERE FOUND TO BE DAMAGED. DURING TESTING, THE PUMP POWERED ON NORMALLY WITH THE RETURNED BATTERY CAP. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE WITH NO POWER REBOOTS, POWER LOSSES OR CALL SERVICE ALARMS OCCURRING. NO POWER LOSSES OCCURRED DURING INVESTIGATION. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS OBSERVED INSIDE THE 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS NOTED 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
    298827 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR