BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2363465 · Received December 8, 2011

    Report

    Report Number
    2531779-2011-09134
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Report Date
    November 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2012: THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RETAINED SAMPLE FROM LOT #B201643 WAS TESTED. THE CARTRIDGE PASSED VISUAL INSPECTION, NOT DAMAGES OR DEFECTS WERE OBSERVED ON THE LUER, O-RINGS, PLUNGER, OR CARTRIDGE BODY. A FORCE TEST WAS PERFORMED WITH NO FAILURES DETECTED. THE PUMP HAS NOT BEEN RETURNED FOR INVESTIGATION AS OF THIS DATE. AN ADDITIONAL SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE PUMP IS RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A "NO CARTRIDGE DETECTED" WARNING WAS OBSERVED IN THE BLACK BOX ON (B)(6) 2011. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR WARNINGS OBSERVED. A CRACK IN THE CONNECTION BETWEEN THE FORCE SENSOR TRACE AND THE PIN PAD WAS FOUND ON INVESTIGATION. CORRECTION NUMBER:2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT ALLEGED THAT THEY OBTAINED A LOW CARTRIDGE AT 20 UNITS AND THEN GOT EMPTY CARTRIDGE. THE PATIENT THEN ATTEMPTED TO FILL CARTRIDGE WITH 20 UNITS TO TIDE HER OVER AND STILL OBTAINED A NO CARTRIDGE DETECTED. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE AND THE PRODUCT WAS REPLACED. THE PATIENT DENIED ANY SYMPTOMS OR SOUGHT ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE COMPLAINT IS BEING REPORTED SINCE THE NO CARTRIDGE ISSUE WAS NOT RESOLVED.

    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 43 YR