BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3772080 · Received April 25, 2014

    Report

    Report Number
    2531779-2014-11364
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE CARTRIDGE 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: THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. A RETAIN SAMPLE FROM THE SAME LOT OF CARTRIDGE WAS TESTED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE RETAIN CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST, A FORCE TEST AND A LEAK TEST WERE PERFORMED ON THE RETAIN SAMPLE AND IT MET PASSING CRITERIA. THE CARTRIDGE FORCE READINGS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS; NO FAILURES RELATED TO THE LOSS OF PRIME COMPLAINT WERE NOTED. 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. A REVIEW OF INCOMING INSPECTION RECORD INDICATED THAT THE LOT MET RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED TO ANIMAS AND TESTED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE RETURNED CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FORCE TEST AND A FILL TEST WERE PERFORMED ON THE RETURNED PRODUCT AND IT MET PASSING CRITERIA. A REVIEW OF INCOMING INSPECTION RECORD INDICATED THAT THE LOT MET RELEASE CRITERIA. THE CARTRIDGE FORCE READINGS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS; NO FAILURES RELATED TO THE LOSS OF PRIME COMPLAINT WERE NOTED. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. REPORTEDLY, THE PUMP EMITTED MULTIPLE LOSS OF PRIME ALERTS. THE REPORTER STATED THAT THERE WAS NO SUDDEN CHANGE IN FORCE OR TEMPERATURE AND THE CARTRIDGE CAP WAS SECURED. REVIEW OF CARTRIDGE USAGE TECHNIQUES INDICATED THAT THE INSTRUCTION FOR USE WAS FOLLOWED. 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
    251696 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION D200056

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR