BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2233308 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06456
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    June 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN, PARTIALLY DISLODGED FORCE SENSOR PINS, AND THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF SPECIFICATION. DURING THE "EZPRIME" OPERATION THE PUMP DETECTED THE CARTRIDGE DURING THE LOAD STEP AND THE PRIME VOLUME WAS NORMAL. THERE WAS NO LOAD STEP MALFUNCTION DETECTED IN THE PUMP HISTORY. SEVERAL LARGE PRIME VOLUMES WERE VERIFIED IN THE PUMP HISTORY. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CORRECTION # 2531779-03/24/2010/003-R. DEVICE EVALUATION COMPLETED ON (B)(4) 2011.

    Description of Event or Problem · 1

    EVALUATION REVEALED A MISALIGNED DISPLAY SCREEN, PARTIALLY DISLODGED FORCE SENSOR PINS, AND THAT THE FORCE SENSOR RESISTANCE READING WAS OUTSIDE OF SPECIFICATION. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 15 YR