BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 2693686 · Received August 13, 2012

    Report

    Report Number
    1823260-2012-04058
    Event Type
    Malfunction
    Date Received
    August 13, 2012
    Date of Event
    July 19, 2012
    Report Date
    August 13, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    REPORTER ALLEGES OBTAINING THE FOLLOWING PEFORMA SYSTEM RESULTS AT THE FOLLOWING TIMES ON (B)(6) 2012: 201 MG/DL AT 6:06 107 MG/DL AT 6:09 110 MG/DL AT 6:13. REPORTER ALLEGES OBTAINING THE FOLLOWING PEFORMA SYSTEM RESULTS AT THE FOLLOWING TIMES ON (B)(6) 2012: 284 MG/DL AT 22:08 139 MG/DL AT 22:13 138 MG/DL AT 22:15. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 470792

    Patients

    Seq Age Sex Outcome Treatment
    1