BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2701210 · Received August 15, 2012

    Report

    Report Number
    2531779-2012-08613
    Event Type
    Injury
    Date Received
    August 15, 2012
    Report Date
    July 23, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: A RETAINED CARTRIDGE SAMPLE FROM LOT # B201828 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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) 2012, THE REPORTER CLAIMED THE PATIENT'S BLOOD GLUCOSE READING ELEVATED TO 600 MG/DL AFTER THE SUBJECT PUMP CEASED INSULIN DELIVERY DUE TO LOSS OF PRIME WARNINGS. REPORTEDLY, THE PATIENT IS A LITTLE CHILD AND CAN IGNORE THE PUMP'S BEEPS/VIBRATIONS/WARNINGS. THE PATIENT WAS PLAYING ON THE PLAYGROUND ALL AFTERNOON AND DID NOT TELL ANYONE ABOUT THE LOSS OF PRIME WARNING. WHEN THE PATIENT CAME HOME, HER MOTHER CHECKED HER BLOOD GLUCOSE READING AT 600 MG/DL. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR SIGNS THAT WOULD SUGGEST HYPERGLYCEMIA AT THE TIME OF CONCERN. THE PATIENT'S ELEVATED BLOOD GLUCOSE RETURNED TO NORMAL WITHIN 2 HOURS AFTER THE LOSS OF PRIME ISSUE WAS RESOLVED WITH TRAINING. DURING TROUBLESHOOTING, THE REPORTER ACKNOWLEDGED THE HYPERGLYCEMIA WAS DUE TO THE LOSS OF PRIME ISSUE. THE PATIENT WENT WITHOUT INSULIN FOR AN EXTENDED PERIOD AFTER THE PUMP ALARMED. IN ADDITION, THE REPORTER BELIEVES THE LOSS OF PRIME COULD HAVE BEEN ATTRIBUTED TO THE WAY THE PATIENT WAS PLAYING ON THE PLAYGROUND. THE SUBJECT PUMP PROVIDED WARNING OF A LOSS OF PRIME ISSUE AS INTENDED PER IFU; HOWEVER, DUE TO USE ERROR THE PATIENT NEVER SOUGHT ASSISTANCE WITH THE ISSUE. THERE WAS NO EVIDENCE OF A PRODUCT MALFUNCTION ASSOCIATED WITH THE INCIDENT. THE LOSS OF PRIME ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING REPORTED DUE TO POSSIBLE USE ERROR AND BECAUSE THE PATIENT ALLEGEDLY HAD ELEVATED BLOOD GLUCOSE ABOVE 500 MG/DL WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201828

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Life Threatening| R