BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2881917 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14918
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 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

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED FOR EVALUATION; A RETAIN CARTRIDGE SAMPLE OF THE SAME LOT HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: 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 DEVICE 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. USER ERROR CANNOT BE DISCOUNTED AS A CONTRIBUTING FACTOR TO THIS EVENT, AS THE PATIENT WAS NOT CYCLING THE CARTRIDGES AT ALL PRIOR TO USE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: THE PUMP EMITTED A LOSS OF PRIME (B)(6) 2012. SHE DID NOT CALL CUSTOMER SUPPORT(CTS) AND THEN HAD A BLOOD GLUCOSE (BG) ELEVATION TO 570 MD/DL WITH UNKNOWN KETONES. SHE WENT TO EMERGENCY ROOM AS SHE DID NOT KNOW WHAT TO DO. SHE WAS ADMITTED TO THE HOSPITAL THAT DAY FOR HER HIGH BG AND RECEIVED UNKNOWN IV THERAPY. SHE WAS TAKEN OFF THE PUMP AND HAS BEEN GETTING INSULIN VIA IV AND "SHOTS" SINCE IN THE EMERGENCY ROOM. SHE WAS BEING MOVED TO A FLOOR BED AT THE TIME OF THE CALL TO CTS. UPON TROUBLESHOOTING CTS NOTED THAT THE PATIENT IS NOT CYCLING THE CARTRIDGES AT ALL PRIOR TO USE. THERE IS NO STRUCTURAL DAMAGE TO THE PUMP SEE, THE CARTRIDGE CAP IS INTACT AND SNUGLY FITTING, AND THE PATIENT DOES NOT REUSE CARTRIDGES. SHE UNSURE WHEN SHE DID HER SITE AND SET CHANGE BEFORE (B)(6) 2012 EVENT- SHE TYPICALLY USES SITE/SET/CART 2-3 DAYS ONLY. THERE ARE NO BLUNT FORCE ISSUES OR ENVIRONMENTAL ISSUES IDENTIFIED AT THIS TIME. CTS RECOMMENDED TO WATCH THE PUMP NOW THAT IT HAS A NEW CARTRIDGE THAT WAS PROPERLY CYCLED PRIOR TO USE AND TO REPORT ANY AND ALL ISSUES TO CTS IMMEDIATELY. ALSO RECOMMENDED SHE SPEAK WITH THER PHYSICIAN PRIOR TO GOING BACK ON THE PUMP. CTS CONTACTED THE PATIENT ON (B)(6) 2012, AND FOUND SHE WAS DISCHARGED (B)(6) 2012 HER CURRENT BG IS 212MG/DL (NO KETONES CHECKED, NO SIGNS OR SYMPTOMS) AND IS FEELING MUCH BETTER. PUMP IS WORKING FINE- WENT OVER PROPER CYCLING OF CARTRIDGES AGAIN AND MAKING SURE SHE ALWAYS CHECK HER EXPIRATION DATES. IT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON INSULIN PUMP THERAPY WAS HOSPITALIZED FOR HYPERGLYCEMIA. USER ERROR CANNOT BE DISCOUNTED AS A CONTRIBUTING FACTOR TO THIS EVENT, AS THE PATIENT WAS NOT CYCLING THE CARTRIDGES AT ALL PRIOR TO USE.

    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 B201639

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization