BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 3173646 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03664
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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. THIS MEDWATCH IS FOR THE PERFORMA COMBO SYSTEM. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE MOBILE SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 2 MINUTES: 81 MG/DL (PERFORMA COMBO SYSTEM) AND 40 MG/DL (MOBILE SYSTEM). THE CUSTOMER HAD HYPOGLYCEMIC SYMPTOMS OF TREMBLING AT THE TIME OF THE RESULTS. THE CUSTOMER SELF-TREATED WITH A BANANA AND FELT BETTER IN 5 MINUTES. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272995 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471033

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male ASPEGIC| CARDENSIEL| UNSPECIFIED CHOLESTEROL TABLET| CARDENSIEL| UNSPECIFIED CHOLESTEROL TABLET| ASPEGIC