BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2213057 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05925
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 HISTORY INDICATED NO POWER ISSUES WITH THE PUMP. THE ALARM HISTORY SHOWED MULTIPLE CALL SERVICE 052 ALARMS. NO DAMAGE WAS FOUND TO BE BATTERY COMPARTMENT OR CAP. THE BATTERY CAP WAS TESTED AND NO CONNECTION DEFECTS WERE FOUND. THE BATTERY CAP WAS ABLE TO SECURE PROPERLY TO THE PUMP. THE PUMP POWERED ON AND WAS EXERCISED FOR 24 HOURS WITHOUT ALARMS OR POWER EVENTS. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN 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. (B)(6).

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT BLOOD GLUCOSE ELEVATED TO 400 MG/DL DUE TO THE POWER ISSUE. THE PATIENT'S CURRENT BLOOD GLUCOSE IS 321 MG/DL. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS THAT WOULD SUGGEST A SERIOUS INJURY. REPORTEDLY, THE ANIMAS PUMP REBOOTED 5-6 TIMES WITHIN THE PAST 3-4 DAYS. THE REPORTER INDICATED THAT THE BATTERY CAP IS SECURE. THERE WAS NO TRAUMA TO THE PUMP. THE SUBJECT PUMP IS EXPOSED TO THE SHOWER WATER. TROUBLESHOOTING COULD NOT BE COMPLETED BECAUSE THE REPORTER DID NOT HAVE THE PUMP AT HAND. THE PRODUCT IS BEING RETURNED FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED POWER ISSUE. THE PATIENT DID NOT HAVE ANY NO MEDICAL INTERVENTION, SYMPTOMS, OR BLOOD GLUCOSE RESULT THAT MEET ANIMAS CRITERIA OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR