BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3801473 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-13073
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP. THE BATTERY CAP WAS UNABLE TO FULLY TIGHTEN AND THE THREADS ON THE CAP WERE DAMAGED. A POWER LOSS WAS NOT DUPLICATED. THERE WAS A CRACK IN THE BATTERY COMPARTMENT FROM THE THREAD AREA TO THE CASE SEAL. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE BATTERY COMPARTMENT. THERE WERE MULTIPLE UNEXPLAINABLE PUMP REBOOT EVENTS OBSERVED IN THE BLACK BOX HISTORY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOTS, LOSS OF POWER, OR CALL SERVICE ALARMS DUPLICATED. THE LEAK TEST SHOWED A LEAK AT THE BATTERY COMPARTMENT CRACK. THERE WAS NO EVIDENCE OF ADDITIONAL MOISTURE OBSERVED INSIDE THE PUMP WHEN THE CASE WAS REMOVED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER STATED THAT THERE WAS MOISTURE IN THE BATTERY COMPARTMENT AND THE PUMP WAS EXPERIENCING INTERMITTENT POWER. 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
    277408 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR