BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3703552 · Received March 27, 2014

    Report

    Report Number
    2531779-2014-07940
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Report Date
    March 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    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

    (B)(4) - DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE WAS EVALUATED BY PRODUCT ANALYSIS (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A RETAIN SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FORCE TEST, AND FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF THE CARTRIDGE. 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

    (B)(4) - CORRECTION: THE PUMP¿S LOT NUMBER WAS INADVERTENTLY SUBMITTED AS 202000. THE CORRECT LOT NUMBER IS B202000.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS EMITTING MULTIPLE LOSS OF PRIME ALARMS. THE REPORTER WAS ADVISED TO USE A CARTRIDGE FROM A DIFFERENT BOX AND TO CALL ANIMAS CUSTOMER TECHNICAL SUPPORT IF THE ISSUE PERSISTS. 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
    181586 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION 202000

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR