BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 3140664 · Received May 31, 2013

    Report

    Report Number
    1823260-2013-03292
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 6, 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
    BR
    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 PERFORMA NANO SYSTEM. THE CUSTOMER USED ALL 3 STRIP LOTS ON BOTH SYSTEMS: LOT NUMBER: 470975 EXPIRATION 10/31/2013 LOT NUMBER: 470929 EXPIRATION 09/30/2013 LOT NUMBER: 470758 EXPIRATION 07/31/2013. RETENTION TESTING PERFORMED ON: LOT NUMBER: 470929 EXPIRATION 09/30/2013 LOT NUMBER: 470758 EXPIRATION 07/31/2013.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE PERFORMA COMBO SYSTEM WITHIN 8 MINUTES: 30 MG/DL AND 446 MG/DL, 446 MG/DL AND 209 MG/DL RESULT OF 446 MG/DL WAS NOT DUPLICATED. RESULTS WERE OBTAINED AT DIFFERENT TIMES. REPORTER ALSO STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 7 MINUTES: 430 MG/DL, 514 MG/DL, 327 MG/DL, 131 MG/DL (PERFORMA COMBO SYSTEM) 212 MG/DL (PERFORMA NANO SYSTEM) ALL READINGS OCCURRED WITH THREE DIFFERENT STRIP LOTS. CUSTOMER IS NOT SURE WHICH STRIP LOT PRODUCED WHICH RESULTS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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
    241767 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male