BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS TSH

    MDR report key: 10906590 · Received November 25, 2020

    Report

    Report Number
    8020790-2020-00124
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    December 23, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JLW
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN GERMANY REGARDING FALSELY UNDERESTIMATED RESULTS WHILE TESTING EXTERNAL QUALITY CONTROL SAMPLES (BIORAD LEVEL 1 AND LEVEL 2 CONTROLS) WITH THE VIDAS® TSH 60 TESTS (REF 30400, LOT 1007944790). THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, OR PACKAGING PROCESSES. THERE WERE NO CAPA OR NONCONFORMITIES LINKED TO THE CUSTOMER'S COMPLAINT. A STUDY ON THREE (3) INTERNAL SERA CONTROL CHARTS ON EIGHT (8) VIDAS BATCHES, INCLUDING THE LOT OF THE CUSTOMER¿S (VIDAS® TSH LOT 1007944790 / 210224-0) WAS PERFORMED. ALL OF THE RESULTS WERE WITHIN SPECIFICATIONS. VIDAS® TSH 1007944790 / 210224-0 WAS IN TREND COMPARED TO THE OTHER BATCHES. THE COMPLAINT LABORATORY TESTED THREE (3) INTERNAL SAMPLES ON THE RETAIN KIT VIDAS® TSH LOT 1007944790 / 210224-0. THE RESULTS WERE IN THE EXPECTED VALUES. BIOMERIEUX REQUESTED THE CUSTOMER TO RETURN THEIR SAMPLE; HOWEVER, THE SAMPLE WAS NOT AVAILABLE. THE LAB ORDERED SAMPLES FROM BIORAD. THEY TESTED THE 3 LEVELS BIORAD SAMPLES 30460 ON THE RETAIN KIT OF VIDAS® TSH LOT 1007944790 / 210224-0. ALL THREE (3) RESULTS WERE IN RANGE. ACCORDING TO THE ANALYSIS OF THE CONTROL CHARTS, AND RESULTS OBTAINED ON THE INTERNAL AND BIORAD SAMPLES, THE PERFORMANCE OF VIDAS® TSH LOT 1007944790 / 210224-0 IS WITHIN THE EXPECTED SPECIFICATIONS. THE INVESTIGATION DID NOT REPRODUCE THE VALUE OUT OF RANGE FOR THE L1 AND L2 OBTAINED BY THE CUSTOMER. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED FOR VIDAS® TSH LOT 1007944790. THE INVESTIGATION DATA SUPPORTS THAT VIDAS® TSH LOT 1007944790 / 210224-0 IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSELY UNDERESTIMATED RESULTS WHILE TESTING EXTERNAL QUALITY CONTROL SAMPLES (BIORAD LEVEL 1 AND LEVEL 2 CONTROLS) WITH THE VIDAS® TSH 60 TESTS (REF 30400, LOT 1007944790). LEVEL 1 (LOT 40361): TARGET VALUE OF BIORAD: 0.38 MIU/L. RILIBÄK RANGE: 0.38 MIU/L +/- 13.5 % = 0.33 ¿ 0.43 MIU/L. THE CUSTOMER MUST CONFORM TO THE RILIBÄK RANGE. CUSTOMER RESULTS OF LEVEL 1: 0.3 MIU/L = INVALID. LEVEL 2 (LOT 40362): TARGET VALUE OF BIORAD: 37 MIU/L. RILIBÄK RANGE: 37 MIU/L +/- 13.5 % = 33 - 43 MIU/L. THE CUSTOMER MUST CONFORM TO THE RILIBÄK RANGE. CUSTOMER RESULTS OF LEVEL 2: 30.75 MIU/L = INVALID. AS TESTING WAS PERFORMED ON EXTERNAL QUALITY CONTROL SAMPLES, THERE ARE NO PATIENTS INVOLVED. NOTE: REFERENCE 30400 IS NOT REGISTERED IN THE UNITED STATES. THE U.S SIMILAR DEVICE IS PRODUCT REFERENCE 30400-01 (K141133). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371293 VIDAS TSH VIDAS® TSH JLW BIOMERIEUX SA 1007944790

    Patients

    Seq Age Sex Outcome Treatment
    1