BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2990807 · Received March 5, 2013

    Report

    Report Number
    2531779-2013-02390
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PRIME HISTORY HAS SEVERAL LARGE PRIMES RECORDED. A FULL REWIND, LOAD AND PRIME SEQUENCE WAS PERFORMED SUCCESSFULLY WITH NO ISSUES. THE FORCE SENSOR CALIBRATION WAS OUT OF SPECIFICATIONS. THE FORCE SENSOR WAS REMOVED FROM MOTOR ASSEMBLY AND THE FORCE SENSOR PLATE WAS CONTAMINATED WITH A GREEN SUBSTANCE. THE FORCE SENSOR PLATE RESISTANCE READING WAS OUT OF SPECIFICATIONS. THE FORCE SENSOR PLATE RESISTANCE WAS OUT OF SPECIFICATIONS. THERE WAS A BAD FORCE SENSOR CALIBRATION LOW. THE BATTERY COMPARTMENT WAS CRACKED. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A SCRATCHED, DIM DISPLAY SCREEN AND WORN KEYPAD SYMBOLS, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS. 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE SENSOR PLATE WAS CONTAMINATED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93588 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR