BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS RUB IGG II 60 TESTS - 30221

    MDR report key: 9856829 · Received March 19, 2020

    Report

    Report Number
    8020790-2020-00033
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    February 8, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    LFX
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE REGARDING FALSE POSITIVE RESULTS FOR A PATIENT TESTED WITH VIDAS RUB IGG II 60 TESTS (REF. (B)(4) LOT 1007673260). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: NO CAPA OR NON-COMPLIANCE RELATED TO THE REASON FOR THE COMPLAINT. ACCORDING TO THE ANALYSIS OF THE QUALITY DATA, NO ANOMALIES DURING THE MANUFACTURING, CONTROL AND PACKAGING STAGES, IN CONNECTION WITH THE REASON FOR THE COMPLAINT. OBSERVATION OF FOUR (4) INTERNAL SAMPLES ON FIVE (5) LOTS OF VIDAS RUB GII, INCLUDING THE CLIENT LOT REVEALED THE CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. THE RESULTS OBTAINED FOR CALIBRATION AND CONTROLS ARE IN ACCORDANCE WITH THE MLE DATA FOR THE CUSTOMER'S LOT. NEGATIVE INTERNAL SAMPLES TEST RESULTS OBTAINED FOR THE CALIBRATION AND THE CONTROLS CONFORM TO THE MLE DATA. THE RESULTS OBTAINED CONFORM TO THE EXPECTED STANDARDS. HOWEVER, THERE IS A NEGATIVE SHIFT IN RESULTS TOWARDS HIGH STANDARDS. THE SAMPLE WAS RETURNED AND TESTED WITH CUSTOMER LOT AND TWO OTHER LOTS. THE POSITIVE RESULT WAS CONFIRMED ON THE THREE (3) REAGENT LOTS, HOWEVER THE RESULTS VARIED. A DILUTION TEST WAS PERFORMED ON THE CUSTOMER LOT AND THERE WAS NO EVIDENCE OF INTERFERENCE. A TEST WAS PERFORMED BY BIOMNIS AND CONFIRMED THE RESULTS OBTAINED BY THE CUSTOMER WITH THE SAME TECHNIQUE AND MADE IT POSSIBLE TO RULE OUT A TUBE ERROR. THE VIDAS RUBG II (REF: (B)(4) LOT: 1007673260 / 201010-0) STILL COMPLIED WITH ITS SPECIFICATIONS. THE ANOMALY ENCOUNTERED BY THE CLIENT WAS RELATED TO THE SAMPLE. THE ABSOLUTE CAUSE OF THIS FALSE POSITIVE RESULT IS NOT CLEAR.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY OBSERVED FALSE POSITIVE RESULTS FOR A PATIENT TESTED WITH VIDAS RUB IGG II 60 TESTS (REF. 30221, LOT 1007673260, EXPIRY DATE 10-OCT-2020). THE CUSTOMER OBTAINED THE FOLLOWING RESULTS FOR A PATIENT¿S SAMPLE TESTED WITH VIDAS RUB IGG II 60 TESTS, LOT 1007673260 ON 08-FEB-2020: INITIAL TESTING RESULT = 46 IU/ML (POSITIVE); RE-TESTING RESULT = 59 IU/ML (POSITIVE). TESTING OF THE PATIENT¿S SAMPLE VIA ALTERNATE METHODS PROVIDED THE FOLLOWING RESULTS: ARCHITECT ABBOTT RESULTS = 0.00 IU/ML (NEGATIVE) AND 0.4 IU/ML (NEGATIVE); WITH CHIMILUMINESCENCE TECHNIC, LIAISON DIASORIN RESULT: < 3 IU/ML (< 7 IU/ML: NEGATIVE). THE CUSTOMER INDICATED THAT CORRECT "NEGATIVE" RESULTS WERE COMMUNICATED TO THE PHYSICIAN. THERE IS NO EVIDENCE OF ANY ADVERSE HEALTH OUTCOME FOR THE PATIENT RELATED TO THIS ISSUE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317134 VIDAS RUB IGG II 60 TESTS - 30221 VIDAS RUB IGG II 60 TESTS - 30221 LFX BIOMÉRIEUX, SA 1007673260

    Patients

    Seq Age Sex Outcome Treatment
    1