BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3161410 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08042
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 (B)(4) - DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201948 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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)(6). THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. 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. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE (BG) OF 15 MMOL/L WITH SMALL KETONES PRESENT. THE REPORTER STATED THE PATIENT RESPONDED TO A BOLUS VIA SYRINGE AND THE BG LOWERED TO WITHIN NORMAL RANGE. AT THE TIME OF THE CALL, THE PATIENT¿S BG WAS REPORTEDLY 6 MMOL/L WITHOUT SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA OR HYPOGLYCEMIA. DURING TROUBLESHOOTING WITH THE REPORTER, IT WAS NOTED IN THE PUMP'S BOLUS HISTORY THAT NOT ALL THE INTENDED BOLUSES WERE DELIVERED. TROUBLESHOOTING WITH THE REPORTER REVEALED THAT DURING SITE/SET CHANGES, THE CARTRIDGE WAS BEING OVER CYCLED; THE REPORTER CONFIRMED CYCLING THE CARTRIDGE 10 TIMES PRIOR TO FILLING. THE REPORTER ALSO DESCRIBED AN IMPROPER TECHNIQUE WHEN COCKING THE INFUSION SET FOR INSERTION. THE REPORTER WAS ADVISED OF THE PROPER TECHNIQUE. THE REPORTER ALSO COMMENTED THAT THE PATIENT DOES NOT ROTATE INFUSION SITES WELL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY DUE TO IMPROPER TECHNIQUE DURING SITE/SET CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262782 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening| R