BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2073117 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01826
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE PUMP DID NOT DETECT THE CARTRIDGE DURING THE LOAD STEP AND DISPENSED FLUID FROM THE CARTRIDGE, EMITTED A "NO CARTRIDGE DETECTED" WARNING. REVIEW OF THE PUMP HISTORY REVEALS ZERO FORCE LOSS OF PRIME WARNINGS AND TWO "NO CARTRIDGE DETECTED' WARNINGS. THE PUMP WAS OPENED AND A MISALIGNED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS WERE OBSERVED. THE FORCE SENSOR RESISTANCE READING FAILS SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT REPORTS PUMP DISPENSED INSULIN DURING LOAD CARTRIDGE PHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1