BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2152898 · Received July 7, 2011

    Report

    Report Number
    2531779-2011-04758
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2011 ALLEGING THAT HE WAS HOSPITALIZED FOR AN ELEVATED BLOOD GLUCOSE (BG). THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2011 HE OPENED A NEW VIAL OF NOVOLOG U100 INSULIN. THE FOLLOWING EVENING THE PATIENT CLAIMED HIS BG AT BEDTIME WAS 300 MG/DL AND GAVE CORRECTION VIA PUMP. THE PATIENT STATED HE ALSO CHANGED SITE THAT EVENING. ON THE MORNING OF (B)(6) 2011, THE PATIENT REPORTED THAT HE WOKE UP WITH A BG OF 528 MG/DL RANGE. THE PATIENT CLAIMED HE THEN CHANGED OUT SITE, SET AND CARTRIDGE AND TOOK A 10.20 UNIT BOLUS WITH PUMP. AT 10:50AM HE RECHECKED HIS BLOOD GLUCOSE AND OBTAINED A MESSAGE OF "HI" (BG > 600 MG/DL). THE PATIENT BOLUSED 6 UNITS WITH PUMP AND CONTINUED TO MONITOR HIS BLOOD GLUCOSE THROUGHOUT THE DAY; HOWEVER, IT DID NOT COME DOWN. THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2011 HE WENT TO SEE HIS PHYSICIAN DUE TO THE HIGH BG'S. THE PATIENT CLAIMED THAT HIS PHYSICIAN ADMITTED HIM INTO HOSPITAL FOR A HIGH BG IN THE 800 MG/DL RANGE. DURING HOSPITALIZATION, THE PATIENT STATED HE WAS REMOVED FROM THE PUMP AND PLACED ON AN INSULIN DRIP AND IV FLUIDS. THE PATIENT CLAIMED HIS BG RETURNED TO NORMAL (100 MG/DL RANGE). AFTER BG RETURNED TO NORMAL RANGE, THE PATIENT REPORTED THAT HE WAS PLACED BACK ON THE PUMP. HOWEVER, AFTER BEING PLACED BACK ON THE PUMP, THE PATIENT STATED HIS BG BEGAN TO RISE AGAIN (BGS OF 495,, 595 AND 695 MG/DL) AND WAS TAKEN OFF THE PUMP AFTER HIS BG WOULD NOT RESPOND TO PUMP CORRECTIONS. THE PATIENT STATED HE WAS DISCHARGED ON (B)(6) 2011 AND ADVISED TO REMAIN ON INSULIN INJECTIONS. AT THE TIME OF TROUBLESHOOTING, IT WAS CONFIRMED THAT ALL SETTINGS (INCLUDING DATE AND TIME) AND DELIVERY HISTORY ON THE PUMP WERE CORRECT. IT WAS NOTED THAT THE INFUSION SET/CARTRIDGE WERE NOT AVAILABLE FOR REVIEW. IT WAS NOTED THAT THE PATIENT HAD COMPLETED ANTIBIOTICS FOR AN ABSCESSED TOOTH. AT THE TIME OF THE CALL, THE PATIENT WAS ADVISED TO USE A NEW INSULIN BOTTLE, SINCE THE PATIENT REPORTED THAT THE HIGH BG EXCURSION BEGAN AFTER HE BEGAN USING A NEW VIAL OF INSULIN AND HAD NOT YET BEEN REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS TREATED FOR HYPERGLYCEMIA BY AN HCP WHILE THE SUBJECT PUMP WAS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R