BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 5970294 · Received September 22, 2016

    Report

    Report Number
    2531779-2016-26463
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Report Date
    August 30, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    UDI-DI
    10840406100129
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: 11/10/2016. DEVICE EVALUATION: NO PRODUCT WAS RETURNED. A RETAINED SAMPLE OF THE SAME CARTRIDGE LOT NUMBER D200101 WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: A LOT REVIEW INVESTIGATION OF THE INCOMING CARTRIDGES PER LOT WAS COMPLETED PRIOR TO RELEASE OF THIS LOT AND ENSURED THAT ALL CARTRIDGES PASSED FOR THIS LOT. THE RETAINED CARTRIDGE SAMPLE WAS FOUND TO PASS THE VISUAL INSPECTION AND THE FILL, FORCE, AND LEAK TESTING. NO DEFECTS WERE FOUND. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THE REPORTER STATED THAT THE CARTRIDGE HAD BEEN CHANGED SINCE THE ISSUE OCCURRED, BUT THE ISSUE HAD NOT OCCURRED WITH AT LEAST THREE CARTRIDGES FROM TWO SEPARATE BOXES. TROUBLESHOOTING INDICATED THAT THE CARTRIDGE CAP WAS SECURE AND CARTRIDGE USE WAS APPROPRIATE PER INSTRUCTIONS FOR USE. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED AS THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623543 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200101 10840406100129

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR