BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER

    MDR report key: 2086102 · Received May 11, 2011

    Report

    Report Number
    2531779-2011-03364
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. PRODUCT ANALYSIS REVIEWED THIS CASE (B)(6) 2011. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201576 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE. 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.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ANIMAS INSULIN CARTRIDGE. (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR/REPORTER CLAIMED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL FROM (B)(6), 2011 TO (B)(6) 2011 FOR DKA. THE PATIENT REPORTEDLY WAS MANAGING HIS/HER DIABETES WITH THE RECALL CARTRIDGE LOT# B201576 PRIOR TO THE HOSPITAL STAY. UPON HIS/HER ADMISSION TO THE HOSPITAL, THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED TO 434 MG/DL WITH SYMPTOM OF DKA. THE PATIENT WAS DISCHARGED FROM THE PUMP TREATMENT AND WAS PUT ON AN INSULIN DRIP UPON ADMISSION. THE PATIENT'S BICARBONATE WAS 11. HER/HIS WHITE BLOOD CELL COUNT REPORTEDLY WAS ELEVATED IN CORRELATION WITH THE HYPERGLYCEMIA. AFTER THE PATIENT'S BLOOD GLUCOSE STABILIZED AT 136 MG/DL, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THE FOLLOWING: THE PATIENT'S BLOOD GLUCOSE REPORTEDLY WAS WELL CONTROLLED PRIOR TO THE HOSPITAL ADMISSION. THERE WAS NO VISIBLE LEAKAGE ON THE REPORTED CARTRIDGE. THE DOCTOR INDICATED THERE WAS NO OBVIOUS PROBLEM WITH THE ANIMAS PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL TREATMENT FOR DKA AFTER THE RECALL LOT# WAS UTILIZED TO MANAGE HIS/HER DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTHER INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| L| R