BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2213287 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05946
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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).

    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: THE PUMP BOOTED TO THE VERIFY SCREEN WITH FUNCTION AUDITORY AND VIBRATORY WARNINGS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT INTERRUPTIONS. A REVIEW OF THE PUMP BLACK BOX SHOWED NO EVIDENCE OF POWER LOSS. UNRELATED TO THE COMPLAINT, THE PUMP DISPLAY WAS FOUND TO BE CRACKED.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE ANIMAS PUMP WILL NOT POWER ON AFTER THE PUMP WAS WORN DURING FOOTBALL PRACTICE. THERE WAS NO PRODUCT MISUSE. THE BATTERY CAP AND COMPARTMENT WAS NOT DAMAGED. THE BATTERY COMPARTMENT WAS CORROSION FREE. THE ISSUE WAS NOT RESOLVED WITH TRAINING. THE PRODUCT WAS SENT BACK FOR INVESTIGATION. THE PATIENT WAS ADVISED TO GO ON THE BACKUP PLAN. THERE WAS NO REPORT OF ANY PATIENT IMPACT ASSOCIATED WITH THE COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR