BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2893168 · Received January 2, 2013

    Report

    Report Number
    2531779-2013-00060
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 7, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY HAS SEVERAL LARGE PRIMES RECORDED. A PUMP REWIND, LOAD AND PRIMES STEPS WERE COMPLETED WITH NO LOSS OF PRIME. A LOAD STEP WAS RAN WITH A CARTRIDGE SET TO 100 UNITS AND AFTER LOAD THE PUMP DISPLAYED 100 UNITS. FORCE SENSOR CALIBRATION WAS OUT OF SPECIFICATIONS. THE FORCE SENSOR PLATE WAS CONTAMINATED. THE FORCE SENSOR PLATE RESISTANCE READING WAS OUT OF SPECIFICATIONS. THERE WAS BAD FORCE SENSOR CALIBRATION LOW. CONTAMINATED FORCE SENSOR AND FORCE SENSOR HIGH.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION WAS FOUND ON THE SENSOR PLATE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR