BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 3210460 · Received July 8, 2013

    Report

    Report Number
    1823260-2013-04070
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 5, 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
    AS
    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 SYSTEM. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE MOBILE SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATES CUSTOMER'S MOBILE SYSTEM IS READING TOO HIGH IN COMPARISON TO HIS PERFORMA SYSTEM. AT APPROXIMATELY 2PM ON WEDNESDAY (B)(6) 2013, CUSTOMER TESTED WITH HIS MOBILE SYSTEM AND RECEIVED A RESULT OF 14.6MMOL/L. CUSTOMER TOOK NO ACTION BASED ON THIS RESULT; HE WAS TIRED AND WENT TO SLEEP. CUSTOMER WOKE UP ABOUT 2:45 PM WITH THE AMBULANCE PERSONNEL AT HIS SIDE. CUSTOMER WAS FOUND UNCONSCIOUS BY HIS WIFE AND SHE CALLED AN AMBULANCE. THEY TOOK HIS BLOOD SUGAR ON AN UNKNOWN SYSTEM WITH A RESULT OF 1.2 MMOL/L. WITHIN 10 MINUTES, THE AMBULANCE THEN TESTED ON CUSTOMER'S PERFORMA DEVICE AND GOT A RESULT OF 4.6 MMOL/L. A TEST WAS THEN RUN WITHIN 10 MINUTES ON CUSTOMER'S MOBILE SYSTEM AND A RESULT OF 9.8 MMOL/L WAS OBTAINED. THE AMBULANCE PERSONNEL ADMINISTERED AN UNKNOWN AMOUNT OF GLUCOSE THROUGH A CANULA. CUSTOMER WAS TREATED ON THE SCENE AND WAS NOT ADMITTED TO HOSPITAL. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310437 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male