BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3022892 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03132
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE BLACK BOX HISTORY WAS REVIEWED AND SHOWED THAT THE PUMP HAD REBOOTED. THE BLACK BOX SHOWED MULTIPLE INSTANCES OF TIME AND DATE RESETTING TO DEFAULT FOLLOWING A REBOOT. THERE WAS NO DAMAGE OBSERVED TO THE BATTERY COMPARTMENT; THE THREADS ON THE BATTERY CAP WERE OBSERVED TO BE STRIPPED AND THE CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION WHEN TESTED; POWER LOSS AND REBOOTS WERE DUPLICATED. THE BATTERY CAP CONTACT HEIGHT AND WIDTH WAS FOUND TO BE WITHIN SPECIFICATIONS. DURING EVALUATION, A TEST CAP WAS USED AND THE PUMP POWERED ON NORMALLY WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE TEST CAP WITH NO FURTHER POWER ISSUES OCCURRING. UNRELATED TO THE COMPLAINT, THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD WAS FOUND TO BE LEAKING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE REPORTER STATED THAT THE BATTERY CAP WILL NOT SECURE PROPERLY AND THE YELLOW RING WAS SEEN. THE BATTERY CAP HAS NEVER BEEN REPLACED AND IS OVER 2 YEARS OLD. 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
    126962 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR