BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2145073 · Received June 30, 2011

    Report

    Report Number
    2531779-2011-04596
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    September 12, 2010
    Report Date
    September 12, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: CARTRIDGE BRAND NAME: ANIMAS INSULIN CARTRIDGE. COMMON DEVICE NAME: INSULIN INFUSION PUMP. CARTRIDGE MODEL #: IR 1200 / 1250 / 2020/ OTP. CATALOG #: 100-124-01. LOT #: B201355. LABELED FOR SINGLE USE? - FOR THE CARTRIDGE, YES; FOR THE PUMP, NO. CORRECTION #: 2531779-03/24/2010-003-R. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2010. DEVICE EVALUATION: A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR RECURRING LOSS OF PRIME WARNINGS. EVALUATION REVEALED PARTIALLY DISLODGED FORCE SENSOR PINS. THIS REPORT IS BEING MADE BASED ON INVESTIGATION RESULTS.

    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 41 YR