BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4042436 · Received August 27, 2014

    Report

    Report Number
    1823260-2014-06576
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    April 27, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER EXPERIENCED SEVERE HYPOGLYCEMIA THAT REQUIRED MEDICAL TREATMENT. THE TIME AND DATE HAD RESET ON THE INFUSION DEVICE; THEREFORE, THE INCORRECT BASAL RATE WAS BEING DELIVERED. THE CUSTOMER'S BLOOD GLUCOSE WAS 2.1 MMOL/L, HE "PASSED OUT," AND HIS PARENTS DELIVERED GLUCAGON AS TREATMENT. THE PARAMEDICS WERE CALLED, AND HIS BLOOD GLUCOSE UPON ARRIVAL WAS 19.1 MMOL/L. HE WAS NOT TRANSPORTED TO THE HOSPITAL AND HAD A "GOOD RECOVERY." THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520743 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 013 YR Required Intervention