BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2936112 · Received January 30, 2013

    Report

    Report Number
    2531779-2013-01393
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. USE ERROR CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR, AS THE PATIENT REUSES SUPPLIES.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED ON (B)(4) 2013: NO CARTRIDGE WAS RETURNED FOR INVESTIGATION; A RETAIN SAMPLE WAS PULLED FOR INVESTIGATION AND PASSED VISUAL, FILL, FORCE AND LEAK TESTS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A HOSPITAL NURSE CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT IS HOSPITALIZED FOR MULTIPLE ISSUES. CUSTOMER TECHNICAL SUPPORT (CTS) CALLED THE PATIENT IN THE HOSPITAL, WHO REPORTS SHE RAN OUT OF SUPPLIES. SHE USES SUPPLIES FOR "A LOT OF DAYS" AND REUSES SUPPLIES. SHE REPORTS HER BLOOD GLUCOSE (BG) HAS BEEN ELEVATED, BETWEEN 400-500MG/DL, DUE TO HER NOT CHANGING SETS OUT PROPERLY, BUT WOULD NOT BE MORE SPECIFIC ON BG VALUES. SHE REPORTS SHE WAS TOLD TO GO TO HOSPITAL DUE TO BEING OUT OF SUPPLIES ON SUNDAY WHEN SHE CALLED ANIMAS. SHE IS HOSPITALIZED WITH PNEUMONIA AND A KIDNEY INFECTION AND IS BEING TREATED WITH ANTIBIOTICS. SHE REPORTS SHE IS NOT ON AN INSULIN DRIP IN THE HOSPITAL, BUT BG IS BEING TREATED WITH INJECTIONS. SHE WOULD NOT PROVIDE CURRENT BG WHEN ASKED. SHE REPORTS HER BG HAS BEEN ELEVATED DUE TO NOT CHANGING OUT PROPERLY BUT WOULD NOT BE MORE SPECIFIC ON BG VALUES. CUSTOMER TECHNICAL SUPPORT (CTS) OFFERED TO REVIEW PUMP, BUT THE PATIENT DECLINED AND SAYS BG ELEVATIONS ARE NOT DUE TO THE PUMP, BUT DUE TO NOT CHANGING OUT PROPERLY. SHE IS NOT IMPLICATING PUMP CAUSING ELEVATIONS. THE PATIENT REPORTS SHE DID GET SOME SUPPLIES TODAY AND SHE DOES CHANGE SUPPLIES EVERY 2 DAYS TYPICALLY WHEN SHE HAS THEM. SHE WILL BE USING NEW SUPPLIES TODAY AND RESUMING PUMP, AND IS WORKING ON INFORMATION NEEDED FOR REORDERS. PATIENT DECLINED PROVIDING ANY FURTHER INFORMATION AND ENDED THE CALL. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA. THERE IS NO INDICATION OF PUMP MALFUNCTION. USE ERROR CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40488 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization