BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2151772 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04710
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 11, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION THERE WAS LOSS OF PRIME WARNINGS OBSERVED IN THE PUMP HISTORY, FORCE READINGS DO NOT REACH ZERO. DURING THE LOAD CARTRIDGE STEP THE PUMP FAILS TO RECOGNIZE THE CARTRIDGE. A FORCE SENSOR CALIBRATION TEST REVEALED THE SENSOR IS NOT DETECTING CORRECT FORCE AT 5LBS. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND ON THE FORCE SENSOR SHIM. THE RESISTANCE ON THE FORCE SENSOR MEASURED AND FOUND TO BE OUT OF SPECIFICATIONS. ALSO FOUND WAS CONTAMINATION ON THE FORCE SENSOR AND HIGH RESISTANCE ON THE FORCE SENSOR. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT WHEN SHE CHANGED THE CARTRIDGE THE PUMP CONTINUED TO PRIME OUT INSULIN AFTER SHE RELEASED THE OK BUTTON. THE PATIENT ATTEMPTED TO LOAD NEW CARTRIDGE AND 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 CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female