BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4212174 · Received October 29, 2014

    Report

    Report Number
    2531779-2014-30806
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/08/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT UNEXPLAINABLE POWER REBOOTS WERE RECORDED. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE BUMPER PAD TO THE COVER. THE RETURNED BATTERY CAP WAS ABLE TO BE FULLY SECURED TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. THE BATTERY CAP CONTACT HEIGHT AND WIDTH MEASUREMENTS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OCCURRING. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE WAS FOUND ON THE PRINTED CIRCUIT BOARD AND OTHER INTERNAL COMPONENTS. THERE WAS NO DAMAGE TO THE POWER CIRCUIT OBSERVED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DISCOLORED. THE COMPLAINT THAT THE PUMP WAS LOSING POWER INTERMITTENTLY 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 (INTERMITTENT POWER) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS NOTED THAT A NEW BATTERY WAS INSERTED INTO THE PUMP AND THE PUMP POWERED ON APPROPRIATELY. 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
    691602 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR