BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3233515 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11235
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/11/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PUMP WAS EXERCISED FOR A 24-HR DURATION PERIOD WITH A 1.0U/HR BASAL RATE; AND NO CHANGES IN THE BASAL RATE OCCURRED DURING THIS TIME PERIOD. THE PUMP WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION AT THE CONCLUSION OF THE 29HR FLOW ACCURACY TEST. INVESTIGATORS WERE UNABLE TO DUPLICATE THE REPORTED COMPLAINT. THERE WAS NO DEFECT FOUND.

    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

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT HE WAS IN THE HOSPITAL FOR 2 WEEKS, BEING TREATED FOR A BLOOD GLUCOSE READING GREATER 800 MG/DL. THE PATIENT REPORTEDLY HAD SYMPTOMS OF VOMITING AND DEHYDRATION ON (B)(6) 2013. DURING HIS HOSPITAL STAY, THE PATIENT TAKEN OFF OF INSULIN PUMP THERAPY AND WAS TREATED WITH IV INSULIN. UPON HIS RELEASE FROM THE HOSPITAL, THE PATIENT RESUMED INSULIN PUMP THERAPY. WHILE HE WAS ON INSULIN PUMP THERAPY, IT WAS NOTED THE PATIENT DID NOT GET ANY INSULIN ON (B)(6) 2013 FROM 12 AM TO 2 AM. THE PATIENT DENIED MAKING ANY CHANGES TO THE SUBJECT PUMP PRIOR TO THE ISSUE. DURING TROUBLESHOOTING, THE PATIENT VERIFIED THERE WAS A DISCREPANCY IN THE BASAL SEGMENT ON (B)(6) 2013. THE BASAL SEGMENT WAS NOT PROGRAMMED AS INTENDED FROM 12:30 AM TO 2:30 AM. THE PRODUCT WAS REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED BASAL SEGMENT DISCREPANCY ISSUE. IN ADDITION, THE PATIENT HAD UNEXPLAINED HYPERGLYCEMIA ABOVE 800 MG/DL AND REQUIRED HOSPITALIZATION WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334064 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R