BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2122311 · Received June 13, 2011

    Report

    Report Number
    2531779-2011-04096
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    May 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS. 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. 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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND REPORTED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL. THE PATIENT CLAIMED THAT SHE EXPERIENCED A BG LEVEL OF "547 MG/DL" AND SYMPTOMS OF (B)(6) AND INCREASED THIRST AFTER PERFORMING A SITE/SET CHANGE THE NIGHT BEFORE. THE PATIENT REPORTEDLY ADMINISTERED SELF-TREATMENT BY TAKING 8 UNITS OF INSULIN VIA SYRINGE. SHE RETESTED AN HOUR LATER AFTER THE SELF-TREATMENT WAS TAKEN AND CLAIMED THAT HER BG LEVEL REMAINED IN THE "500 MG/DL" RANGE. THROUGH TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THAT THE PATIENT EXPERIENCED A LOT OF BLEEDING WHEN THE INFUSION SET WAS REMOVED. IN ADDITION, BLOOD WAS OBSERVED IN THE CANNULA. THE PATIENT REPORTEDLY ENDED THE CALL WITH THE REPRESENTATIVE DURING A SET CHANGE. THE SITE APPEARED TO BE HEALTHY AND THE CANNULA WAS NOT BENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED AN ELEVATED BG LEVEL AND SYMPTOMS THAT MEET ANIMAS' CRITERIA FOR A SERIOUS INJURY. THE PATIENT'S INJURY CAN BE ATTRIBUTED TO USE-ERROR SINCE THE PATIENT DID NOT REPLACE THE SITE AS INSTRUCTED AND DID NOT FOLLOW GENERAL PUMP INSTRUCTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening