BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2083569 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03306
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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 FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE ANIMAS INSULIN PUMP IS REBOOTING ITSELF EVERY 6 MINUTES. REPORTEDLY, DUE TO THIS ISSUE, THE PATIENT'S BLOOD GLUCOSE ELEVATED TO 310 MG/DL WITH SYMPTOM OF NAUSEA. THE PATIENT DISCONTINUED USAGE OF THE ANIMAS INSULIN PUMP AND IS CURRENTLY ON A BACKUP PLAN. AT THE TIME OF THE PHONE CALL TO ANIMAS, HER BLOOD GLUCOSE WAS 123 MG/DL. THERE WAS NO MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THE FOLLOWING: THERE WAS NO TRAUMA TO THE PUMP. THE PATIENT DENIED PEELING OR CRACKS. THE THREADS ON BATTERY CAP AND O RING APPEAR NORMAL. THE ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTIONED DUE TO THE ALLEGED SELF REBOOT ISSUE. THERE IS NO EVIDENCE THAT THE PATIENT SUFFERED ACUTE COMPLICATION OF DIABETES.

    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