BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3041019 · Received April 8, 2013

    Report

    Report Number
    2531779-2013-03790
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 PUMP¿S BLACK BOX AND HISTORY WAS REVIEWED AND SHOWED THE PUMP REBOOTED. THERE WAS NO PHYSICAL DAMAGE OBSERVED TO THE RETURNED BATTERY CAP OR BATTERY COMPARTMENT; THE RETURNED BATTERY CAP FASTENED SECURELY AND THE PUMP HELD POWER. THE BATTERY CAP WIDTH AND HEIGHT MEASUREMENTS WERE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH THE RETURNED BATTERY CAP; NO LOSS OF POWER WAS DUPLICATED DURING THIS TIME; THE PUMP WAS STILL DELIVERING AT THE CONCLUSION OF TESTING. UNRELATED TO THE COMPLAINT, TESTING REVEALED THE TIME AND DATE RESETS ON (B)(6) 2013. THE PUMP WAS OPENED AND THE INTERNAL CLOCK BATTERY ON THE PRINTED CIRCUIT BOARD WAS FOUND TO BE LEAKING. THERE WAS NO INTERNAL MOISTURE DAMAGE OR INTERMITTENT CONNECTIONS OBSERVED. THE POWER ISSUE WAS CONFIRMED BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT ANYTIME THE PUMP IS BUMPED, IT REBOOTS. THE PATIENT NOTED THAT THE FIRST TIME THIS HAPPENED, SHE DID NOT NOTICE AND HER BLOOD GLUCOSE (BG) ELEVATED TO 417 MG/DL WITH HEADACHE, SWEATING, AND IRRITABILITY. THE PATIENT REPORTEDLY DELIVERED A CORRECTION BOLUS FOR THE BG ELEVATION. THE PATIENT NOTED THAT THE PUMP HAS BEEN REBOOTING 8 TO 9 TIMES A DAY FOR THE PAST 4 DAYS. THE REPORTED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143784 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR