BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2337491 · Received November 15, 2011

    Report

    Report Number
    2531779-2011-08566
    Event Type
    Malfunction
    Date Received
    November 15, 2011
    Report Date
    October 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 12/08/2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED NO EVIDENCE OF LOSS OF CARTRIDGE DETECTION. DURING TESTING, THE PUMP DID NOT DETECT THE FILLED CARTRIDGE DURING THE LOAD STEP AND DISPENSED FLUID EMITTING A "NO CARTRIDGE DETECTED" WARNING. EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION, THERE WAS A DISLODGED DISPLAY SCREEN, AND PARTIALLY DISLODGED FORCE SENSOR PINS.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510K, K042873.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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. RECALL # 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE ANIMAS INSULIN PUMP DID NOT RECOGNIZE THE LOADED CARTRIDGE DURING THE LOAD STEP. REPORTEDLY, THE INSULIN SHOT OUT DURING THE LOAD STEP UNTIL THERE WERE 140 UNITS LEFT IN THE CARTRIDGE. THERE WAS NO REPORT OF ANY PATIENT IMPACT ASSOCIATED WITH THE REPORTED ISSUE. THIS COMPLAINT IS REPORTED DUE TO THE ALLEGED NO CARTRIDGE DETECTED ISSUE.

    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 42 YR