BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3298759 · Received August 20, 2013

    Report

    Report Number
    2183996-2013-01543
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 15, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR EVALUATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED ON THE ADHESIVE TAPE AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 223479 WAS VERIFIED AND FOUND WITHIN SPECIFICATIONS. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED HE REQUIRED MEDICAL TREATMENT DUE TO HYPOGLYCEMIA ON THE MORNING OF THE REPORT. HE RETURNED HOME IN THE EVENING ON (B)(6) 2013 AND FOUND HIS INFUSION SET HAD PULLED OUT OF HIS SKIN. HIS BLOOD GLUCOSE WAS 351 MG/DL AT 11:29 P.M., AND HE CHANGED THE INFUSION SET AND DELIVERED A 20.0 UNIT INSULIN INJECTION AT 11:45 P.M. HE DELIVERED AN ADDITIONAL 22.0 UNIT INJECTION AT 1:00 A.M. AND A 9.3 UNIT BOLUS AT 2:31 A.M., AND HIS BLOOD GLUCOSE WAS 52 MG/DL AT 4:30 A.M. HIS WIFE CONTACTED THE PARAMEDICS AROUND 7:24 A.M. HE WAS UNCONSCIOUS AND HIS BLOOD GLUCOSE WAS 28 MG/DL, AND HE WAS TREATED WITH LIQUID GLUCOSE AND WAS NOT TRANSPORTED TO THE HOSPITAL. THE PARAMEDICS LEFT AT 8:05 A.M., AND HIS BLOOD GLUCOSE WAS 106 MG/DL. HIS BLOOD GLUCOSE WAS 150 MG/DL AT THE TIME OF THE REPORT, AND HIS NORMAL RANGE IS 90-150 MG/DL. HE BELIEVES HE DELIVERED TOO MUCH INSULIN TO TREAT HYPERGLYCEMIA AND THIS CAUSED HYPOGLYCEMIA. FOLLOW-UP WAS COMPLETED ON (B)(6) 2013, AND HE HAD EXPERIENCED NO FURTHER ISSUES. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401656 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC NA 223479

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR Required Intervention OMACOR FISH OIL PILLS| METOPROLOL| CALCIUM| BABY ASPIRIN| POTASSIUM| NPH INSULIN