BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3983266 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22537
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A RETAIN SAMPLE FROM THE SAME LOT AS THE ALLEGED CARTRIDGE LOT WAS TESTED ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND FILLING THE CARTRIDGE. THE RETAIN SAMPLE PASSED A FORCE TEST WITHIN SPECIFICATIONS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED AT THE LEUR CONNECTION, O RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. A LOT REVIEW WAS ALSO CONDUCTED WITH NO ISSUES FOUND. THE INITIAL REPORT LISTED THE TYPE OF DEVICE AS A PUMP FOR THIS COMPLAINT. THE TYPE OF DEVICE SHOULD HAVE BEEN SET TO CARTRIDGE FOR THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE IS NOT EXPECTED TO BE RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A SEVERE HYPERGLYCEMIC EVENT ON (B)(6) 2014. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE LEVEL OF 600 MG/DL BUT HAD NO SYMPTOMS OR SIGNS OF KETONES. THE REPORTER STATED THAT THE PUMP HAD BEEN EMITTING FREQUENT LOSS OF PRIME ALARMS PRIOR TO THE EVENT. WHILE TROUBLESHOOTING WITH A CUSTOMER TECHNICAL SUPPORT REPRESENTATIVE, IT WAS REVEALED THAT THE PATIENT WAS USING THE CARTRIDGE IMPROPERLY. THERE WAS NO INDICATION THAT THE PATIENT PRIMED WHILE ATTACHED AS A RESULT OF THIS ALLEGED ISSUE. IT WAS ALSO STATED BY THE REPORTER THAT THE PATIENT PRIMED 0.70 UNITS OF INSULIN WHILE STILL ATTACHED TO THE PUMP WHILE RESPONDING TO ONE OF THE LOSS OF PRIME ALARMS. THE REPORTER STATED THAT THE PATIENT REMAINED ON PUMP THERAPY AFTER THE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A SEVERE HYPERGLYCEMIC EVENT WHILE ON PUMP THERAPY AS A RESULT OF USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460074 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200069

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR