BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® RUB IGG

    MDR report key: 8322678 · Received February 8, 2019

    Report

    Report Number
    8020790-2019-00011
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Report Date
    May 27, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFX
    PMA / PMN Number
    K080766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DATE OF THIS REPORT, WAS CORRECTED FROM 05/29/2019 TO 05/27/2019.

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER IN CHILE REPORTING A FALSE NEGATIVE RESULT FOR A CAP SURVEY SAMPLE IN ASSOCIATION WITH THE VIDAS® RUBELLA (RUB) IGG ASSAY. THE CUSTOMER REPORTED A NEGATIVE RESULT (9 IU/ML) USING VIDAS RBG II BATCH 1006549030 /190523-1 AND BATCH 1006620930 /190619-0, WHEREAS IT WAS EXPECTED POSITIVE. ACCORDING TO CAP SURVEY REPORT, THE DISTRIBUTION IS AS FOLLOWED : 95.4% REPORTED PRESENT (167 OUT OF THE 175 VIDAS PARTICIPANTS) 2.9% REPORTED INDETERMINATE (5 PARTICIPANTS) 1.7% REPORTED ABSENT (3 PARTICIPANTS INCLUDING YOUR CUSTOMER). **COMPLAINT TRENDING ANALYSIS** NO OTHER COMPLAINT HAS BEEN RECORDED FOR THE EXTERNAL QUALITY CONTROL ISSUE WITH SIMILAR BEHAVIOR ON VIDAS RBG II BATCH 1006549030 /190523-1 AND BATCH 1006620930 /190619-0. THERE IS NEITHER CAPA NOR NON CONFORMITY LINKED TO THE OBJECT OF THIS ISSUE. ** QUALITY CONTROL RECORDS ** THE ANALYSIS OF VIDAS RBG II BATCHES HISTORY RECORDS FOR THE BATCHES MENTIONED BY THE CUSTOMER (1006549030 /190523-1 AND 1006620930 /190619-0) SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. ** STUDY OF INTERNAL SAMPLES CONTROL CHARTS** THIS ANALYSIS WAS CARRIED OUT ON FOUR INTERNAL SERA WITH DIFFERENT TARGETS ( 3 IU/ML; 11 IU/ML ; 18 IU/ML AND 31 IU/ML) FOR VIDAS RBG II BATCH 1006549030 /190523-1 AND BATCH 1006620930 /190619-0 COMPARED TO FOUR OTHER BATCHES. ALL THE RESULTS WERE WITHIN SPECIFICATIONS AND VIDAS RBG II BATCH 1006549030 /190523-1 AND BATCH 1006620930 /190619-0 ARE IN THE TREND OF THE OTHER LOTS. **TESTS PERFORMED INTERNALLY** FOUR INTERNAL SERA WITH DIFFERENT TARGETS (3 IU/ML ; 11 IU/ML ; 18 IU/ML AND 31 IU/ML) WERE TESTED ON THE TWO BATCHES MENTIONED BY THE CUSTOMER : VIDAS RBG II LOT 1006620930 /190619-0 AND VIDAS RBG II LOT 1006549030/ 190523-1 ALL THE SAMPLES WERE WITHIN THEIR SPECIFICATIONS AND THE RESULTS OBTAINED WERE SIMILAR TO THOSE OBTAINED BEFORE THE BATCHES RELEASE. IT WAS NOT POSSIBLE TO PERFORM TEST ON THE QUALITY CONTROL SAMPLE DUE TO ITS STABILITY. **CONCLUSION** WITHOUT THE SAMPLE, IT IS NOT POSSIBLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE VIDAS RUB IGG II NEGATIVE RESULT. ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS RBG II BATCH 1006549030 /190523-1 AND BATCH 1006620930 /190619-0.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A FALSE NEGATIVE RESULT FOR A (B)(6) SURVEY SAMPLE IN ASSOCIATION WITH THE VIDAS® RUBELLA (RUB) IGG ASSAY. THE CUSTOMER STATED THEY REPORTED THAT RUB IGG ANTIBODIES WERE ABSENT (NEGATIVE) WITH A RESULT OF 9 UI/ML. THE EXPECTED RESULT WAS RUB IGG ANTIBODIES PRESENT (POSITIVE). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112172 VIDAS® RUB IGG VIDAS® RUB IGG LFX BIOMERIEUX SA 1006549030

    Patients

    Seq Age Sex Outcome Treatment
    1