BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3913759 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18957
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT POWER REBOOTS HAD OCCURRED. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AT THE THREADS. THERE WAS VISIBLE CORROSION IN THE BATTERY COMPARTMENT. THERE WAS NO DAMAGE TO THE RETURNED BATTERY CAP. THE BATTERY CAP WAS ABLE TO BE SECURED TO THE PUMP. DURING TESTING, THE PUMP PERFORMED THE REWIND, LOAD, AND PRIME STEPS WITH NO POWER INTERRUPTIONS OCCURRING. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE WITH NO POWER INTERRUPTIONS OCCURRING. A LEAK TEST WAS PERFORMED AND A BATTERY COMPARTMENT LEAK WAS FOUND. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF INTERNAL MOISTURE WAS FOUND ON THE PRINTED CIRCUIT BOARD OR ANY OTHER INTERNAL COMPONENTS. THE COMPLAINT THAT THE PUMP WAS LOSING POWER INTERMITTENTLY WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. 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 ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION IN THE BATTERY COMPARTMENT.THE INDICATED BLOOD GLUCOSE (BG) LEVEL GREATER THAN 250 MG/DL BUT LESS THAN 500 MG/DL WITH NO SIGNS OR SYMPTOMS WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. 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
    389825 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR