BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4027184 · Received August 21, 2014

    Report

    Report Number
    1823260-2014-06372
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER FELT SICK AND RECEIVED THREE BLOOD GLUCOSE RESULTS OF "HI" (> 33.3 MMOL/L). HE DELIVERED A BOLUS OF 6.0 I.U. EACH TIME, BUT THIS DID NOT DECREASE HIS BLOOD GLUCOSE. HE WENT TO THE HOSPITAL, AND HIS BLOOD GLUCOSE WAS 70.0 MMOL/L. HE WAS TREATED WITH AN INSULIN INFUSION AND WAS STILL HOSPITALIZED AT THE TIME OF THE REPORT DUE TO PNEUMONIA. REPORTER STATED THE HOSPITAL BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. THE CUSTOMER SWITCHED TO HIS BACKUP INFUSION DEVICE, AND THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507496 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R