BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3820840 · Received May 20, 2014

    Report

    Report Number
    2531779-2014-14206
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/09/2014. DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED; A RETAINED SAMPLE FROM THE SAME CARTRIDGE LOT WAS PULLED AND EVALUATED BY PRODUCT ANALYSIS ON 06/30/2014 WITH THE FOLLOWING FINDINGS:A CARTRIDGE FILL TEST WAS COMPLETED WITH NO AIR BUBBLES FORMED. A CARTRIDGE LEAK TEST WAS PERFORMED WITH NOTED LEAKS FROM ANYWHERE ON THE CARTRIDGE. A CARTRIDGE FORCE TEST WAS PERFORMED AND CONFIRMED THAT THE REQUIRED FORCES WERE WITHIN SPECIFICATIONS. NO DEFECTS WERE FOUND RELATED TO THE LOSS OF PRIME COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE REPORTER CONTACTED ANIMAS ALLEGING A BLOOD GLUCOSE OF 2.6 MMOL/L WITH DIZZINESS RELATED TO MULTIPLE LOSS OF PRIME WARNINGS ON THE PUMP. THE REPORTER INDICATED THAT THE PUMP EMITTED MANY LOSS OF PRIME WARNINGS REQUIRING REPRIMING OF THE PUMP OCCURRING ON A SINGLE CARTRIDGE. DURING THE REVIEW OF THE PUMP IT WAS FOUND THAT THE PATIENT HAD PRIMED 19.2 UNITS TOTAL BETWEEN (B)(6) 2014 AND THE PATIENT INDICATED THAT THE PUMP WAS NOT DISCONNECTED DURING THE PRIME. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA RELATED TO INCORRECTLY PRIMING WHILE ATTACHED FOR MULTIPLE LOSS OF PRIME WARNINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299775 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening