BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3863726 · Received June 10, 2014

    Report

    Report Number
    2531779-2014-16317
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT UNEXPLAINABLE POWER REBOOTS WERE RECORDED ON (B)(6) 2014. VISUAL INSPECTION REVEALED THAT THERE WERE CRACKS IN THE BATTERY COMPARTMENT IN THE THREAD AREA AND BELOW THE GRIP PAD. THE BATTERY COMPARTMENT THREADS WERE FOUND TO BE DAMAGED. NO BATTERY CAP WAS RETURNED WITH THE PUMP. A TEST BATTERY CAP WAS USED TO COMPLETE ALL TESTING. THE TEST BATTERY CAP WAS NOT ABLE TO BE FULLY SECURED TO THE PUMP; HOWEVER, NO POWER LOSSES OCCURRED DURING TESTING. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT A COMPONENT ON THE PRINTED CIRCUIT BOARD WAS DEFECTIVE. THE INTERMITTENT POWER ISSUE WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    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 BATTERY COMPARTMENT WAS CRACKED. IT WAS NOTED THAT THE BATTERY CAP THREADS WERE STRIPPED. 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
    339462 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR