BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2213185 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05939
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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 BLACK BOX DID NOT INDICATE ANY POWER EVENTS FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED WITHOUT INTERRUPTIONS AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP REBOOTED ITSELF 15 TIMES IN A COUPLE HOURS. THE PATIENT IDENTIFIED THE ISSUE WHEN SHE SAW THE "VERIFY" SCREEN ON THE PUMP. THE PATIENT REPORTED THAT THERE WAS NO TRAUMA TO THE PUMP AND THE PUMP WAS NOT EXPOSED TO WATER. THE PATIENT CONFIRMED THAT HER BLOOD GLUCOSE REMAINED WITHIN TARGET.

    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 18 YR