BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4169444 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29106
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT YET BEEN RETURNED. A RESERVED SAMPLE FROM THE SAME LOT NUMBER U200024 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE WAS NOT RETURNED. A RESERVED SAMPLE FROM THE SAME LOT NUMBER U200024 WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE; THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND DURING FILLING THE CARTRIDGE. THE CARTRIDGE ALSO PASSED THE FORCE TEST. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN 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

    THE INSULIN CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE INSULIN 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA REQUIRING HOSPITALIZATION FOR TREATMENT. THE REPORTER STATED THAT THE PATIENT DID NOT RECEIVE INSULIN DUE TO A LEAK IN THE INSULIN CARTRIDGE. ANIMAS CUSTOMER SUPPORT ATTEMPTED TO CONTACT THE REPORTER IN FOLLOW UP, BUT WAS NOT SUCCESSFUL IN RECEIVING A RESPONSE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION AND THE ALLEGED LEAKING CARTRIDGE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650859 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION U200024

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R