BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173582 · Received July 23, 2011

    Report

    Report Number
    2531779-2011-05173
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWS UNEXPLAINED REBOOTING EVENTS. VISUAL INSPECTION OF THE PUMP DID NOT REVEAL ANY DAMAGE. THE BATTERY CAP WAS ABLE TO SECURELY FASTEN TO THE PUMP. THE PUMP WAS ABLE TO BOOT UP PROPERLY AND WAS EXERCISED FOR 24 HOURS WITH NO ISSUES. THE PUMP WAS OPENED AND NO DAMAGE WAS OBSERVED.

    Description of Event or Problem · 1

    THE PATIENT SAID THE PUMP IS REBOOTING WITHOUT USER INTERVENTION FOR THE PAST TWO DAYS. SHE SAID THE BATTERY CAP IS SECURE AND THAT THE YELLOW O-RING WAS NOT SHOWING. THERE WAS NO STRUCTURAL DAMAGE NOTED TO THE PUMP AND THE BATTERY CAP IS LESS THAN SIX MONTHS OLD. THERE WAS NO EVIDENCE OF MISUSE OF THE PRODUCT. THERE WAS NO VISIBLE CORROSION IN THE BATTERY COMPARTMENT. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR