BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2822846 · Received November 7, 2012

    Report

    Report Number
    2531779-2012-13238
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    RECALL # 2531779-03/24/2010-003-R.

    Additional Manufacturer Narrative · 1

    (B)(4)- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING; THE PUMP DID NOT RECOGNIZE THE CARTRIDGE AND EMITTED A 'NO CARTRIDGE DETECTED' WARNING. INVESTIGATION REVEALED THAT THE FORCE SENSOR IS OUT OF CALIBRATION. THE PUMP WAS OPENED AND A FORCE SENSOR CIRCUIT COMPONENT WAS FOUND TO BE MISALIGNED ON THE PRINTED CIRCUIT BOARD.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED (B)(4) 2013: THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION; A RETAINED SAMPLE FROM THE SAME LOT WAS PULLED FOR INVESTIGATION ON (B)(4) 2012 BY PRODUCT ANALYSIS, AND PASSED VISUAL INSPECTION, CARTRIDGE FILL, AND CARTRIDGE FORCE TESTS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE PUMP GAVE SEVERAL RANDOM WARNINGS THAT THE PUMP WAS NOT PRIMED THEN EJECTED THE INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP AFTER THE CARTRIDGE AND TUBING WERE CHANGED. THE PATIENT WAS VERIFIED NOT TO HAVE BEEN ATTACHED TO THE PUMP AT THE TIME. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    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 18 YR