BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 3833148 · Received May 27, 2014

    Report

    Report Number
    1823260-2014-03724
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    July 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    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. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE PERFORMA SYSTEM (LOT NUMBER 471664, EXPIRATION DATE 02/28/2015). (B)(4). DEVICE WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS RECEIVING A RESULT OF HI (GREATER THAN 33.3 MMOL/L) ON THE PERFORMA COMBO SYSTEM. SHE ADMINISTERED A BOLUS OF HUMALOG BASED ON THIS RESULT. WITHIN 2 HOURS, SHE BECAME HYPOGLYCEMIC AND RECEIVED UNSPECIFIED TREATMENT FROM HER HUSBAND AND DAUGHTER. AT THIS POINT THE CUSTOMER TESTED 22.5 MMOL/L ON THE PERFORMA COMBO SYSTEM AND 4.8 MMOL/L ON THE PERFORMA SYSTEM WITHIN 10 MINUTES. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER THE TEST STRIPS ARE NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311304 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471664

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention HUMALOG| HUMALOG