BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4143579 · Received October 6, 2014

    Report

    Report Number
    1823260-2014-07619
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 29, 2014
    Report Date
    November 7, 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
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER HAS EXPERIENCED 2 ADVERSE EVENTS DUE TO INACCURATE INSULIN DELIVERY. ON (B)(6) 2014, THE CUSTOMER FELT SICK AND ATE DEXTROSE. HE EXPERIENCED A SEIZURE A SHORT TIME LATER, AND PARAMEDICS WERE CALLED. HIS BLOOD GLUCOSE IN THE AMBULANCE WAS 80 MG/DL. ON (B)(6) 2014, HIS BLOOD GLUCOSE WAS 222 MG/DL AT 12:00 A.M. AND HE DELIVERED 4.0 I.U. VIA THE INFUSION DEVICE. HE EXPERIENCED A SEIZURE AT 4:00 A.M., AND HIS WIFE GAVE HIM APPLE JUICE. HIS BLOOD GLUCOSE WAS 52 MG/DL AT 4:26 A.M. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622519 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR Required Intervention