BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® RUB IGG II ASSAY

    MDR report key: 5111728 · Received September 29, 2015

    Report

    Report Number
    3002769706-2015-00107
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 14, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFX
    PMA / PMN Number
    K080766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. NO SAMPLE WAS SUBMITTED BY THE CUSTOMER. EVALUATION OF THE VIDAS® RUBELLA IGG II (LOT 1003903030) INDICATES NO ANOMALY IDENTIFIED DURING MANUFACTURING QC. THERE WAS NO NON-CONFORMITY RELATED TO THE CUSTOMER'S ISSUE. INTERNAL QC SAMPLES (POSITIVE AND EQUIVOCAL) WERE TESTED WITH RETAIN KITS OF THE CUSTOMER LOT. KIT PERFORMANCE WAS IN ACCORDANCE WITH SPECIFICATIONS. IT SEEMS THAT THERE IS ANTI-RUBELLA AB IN THE SERUM, BUT WITH A RATE BELOW THE VIDAS® SYSTEM'S TECHNICAL DETECTION THRESHOLD. THE PACKAGE INSERT FOR VIDAS® RBG II INDICATES SENSITIVITY IS NOT 100%, EVIDENCED IN THE FOLLOWING EXCERPT : "RELATIVE SENSITIVITY WAS ESTABLISHED FOR EACH STUDY IN COMPARISON WITH TWO COMMERCIALIZED REAGENTS. STUDY A: SENSITIVITY: 97.87% (95 % CONFIDENCE INTERVAL: 94.57% - 99.18%). STUDY B: SENSITIVITY: 95.45% (95% CONFIDENCE INTERVAL: 91.74% - 97.54%). SINCE A FEW RARE CASES OF REINFECTION WITH RUBELLA HAVE BEEN REPORTED IN PREVIOUSLY VACCINATED OR INFECTED WOMEN, CERTAIN AUTHORS HAVE SUGGESTED REVACCINATING SUBJECTS AT RISK WHEN THE LEVEL OF ANTI-RUBELLA IGG IS LESS THAN 25 IU/ML. "

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE NEGATIVE RESULT ASSOCIATED WITH THE VIDAS® RUB IGG II ASSAY ((B)(4)). THE CUSTOMER OBTAINED A NEGATIVE RESULT ON VIDAS® (7 UI/ML) ON (B)(6) 2015 FOR A PREGNANT WOMAN WITH THE VIDAS® RUB IGG LOT 1003788010 (EXPIRATION DATE 18-JAN-2016). THE TECHNIQUE COBAS GAVE A POSITIVE RESULT AT 17.41 ON THE SAME SAMPLE. THE PATIENT IS A PREGNANT WOMAN AT (B)(6) OF PREGNANCY. THE CUSTOMER REPEATED THE SAME SAMPLE ON (B)(6) 2015 USING THE KIT VIDAS® RUB IGG LOT 1003903030 (EXPIRATION DATE 16-MAR-2016) AND THE RESULT WAS STILL NEGATIVE AT 7 UI/ML. THE CLINICIAN DID NOT AGREE WITH THESE RESULTS BECAUSE THE PATIENT WAS VACCINATED. THE VIDAS RUB IGG II ((B)(4)) IS NOT SOLD IN THE US; HOWEVER, A SIMILAR PRODUCT VIDAS® RUB IGG ((B)(4)) IS SOLD. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTAL HAS BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION. BIOMERIEUX INTERNAL INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641078 VIDAS® RUB IGG II ASSAY VIDAS® RUB IGG II ASSAY LFX BIOMERIEUX SA 1003788010

    Patients

    Seq Age Sex Outcome Treatment
    1