BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 3884938 · Received June 19, 2014

    Report

    Report Number
    1823260-2014-04492
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 19, 2014
    Report Date
    July 28, 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
    FR
    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.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE PERFORMA NANO SYSTEM WITHIN 1 MINUTE: 96 MG/DL AND 32 MG/DL. AT AN UNSPECIFIED TIME LATER CUSTOMER TESTED ON A DIFFERENT PERFORMA NANO METER AND RECEIVED A RESULT OF 38 MG/DL. NO ACTION WAS TAKEN BASED ON THESE RESULTS AS CUSTOMER PASSED OUT FOLLOWING THEM AND HAD "CONTUSIONS AND CUTS." NO TREATMENT WAS RECEIVED. CUSTOMER HAS SINCE RECOVERED AND IS "FEELS BETTER." THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359940 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 472151

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other INSULIN PUMP| UNSPECIFIED INSULIN| INSULIN PUMP| UNSPECIFIED INSULIN