BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MEASLES IGG ASSAY

    MDR report key: 6067731 · Received October 31, 2016

    Report

    Report Number
    3002769706-2016-00456
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJB
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THEY OBSERVED A LEAKING VIAL FOR THE CONTROL 1 REAGENT CONTAINED IN A VIDAS® (B)(6) IGG ASSAY KIT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE COMPLAINT CONCERNS THE VIDAS® MSG LOT 1004735420 / 170201-0. UPON THE OPENING OF THE BOX, THE CUSTOMER FOUND THE C1 VIAL VIDAS® MSG LOT 1116180 REVERSED AND BADLY SCREWED WITH A LEAK. THE ANALYSIS OF BATCH HISTORY RECORDS OF VIDAS® MSG LOT 1004735420 / 170201-0 SHOWED NO ANOMALY DURING THE PACKAGING. THE ANALYSIS OF BATCH HISTORY RECORDS OF THE C1 VIAL VIDAS® MSG LOT 1116180 SHOWED NO ANOMALY DURING THE FILLING. THE QUALITY CONTROL PERFORMED A SEROLOGICAL CONTROL ON VIDAS® MSG C1 LOT 1116180. (B)(6) SEROLOGY AND THE RESULTS WERE (B)(6) AS MENTIONED IN THE PACKAGE INSERT. "THIS PRODUCT HAS BEEN TESTED AND SHOWN TO BE (B)(6) FOR (B)(6) SURFACE ANTIGEN, AND ANTIBODIES TO (B)(6). HOWEVER, SINCE NO EXISTING TEST METHOD CAN TOTALLY GUARANTEE THEIR ABSENCE, THIS PRODUCT MUST BE TREATED AS POTENTIALLY INFECTIOUS. THEREFORE, USUAL SAFETY PROCEDURES SHOULD BE OBSERVED WHEN HANDLING". THE QUALITY CONTROL LABORATORY CHECKED THE RETAIN KIT VIDAS® MSG LOT 1004735420 / 170201-0: THE VIALS WERE CORRECTLY SCREWED. THERE IS NO OTHER COMPLAINT ON THE VIDAS® MSG LOT 1004735420 / 170201-0 FOR THE SAME ISSUE. THERE IS NO CAPA OR NON-CONFORMITY FOR A SIMILAR ISSUE. THE QUALITY PRODUCT LABORATORY RECOMMEND TO THE CUSTOMER TO WEAR GLOVES WHEN HANDLING REAGENTS IN ACCORDANCE WITH GOOD LABORATORY PRACTICES. A COMMUNICATION TO THE FILLING DEPARTMENT WILL BE PERFORMED INFORMING THEM ABOUT THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THEY OBSERVED A LEAKING VIAL FOR THE CONTROL 1 REAGENT CONTAINED IN A VIDAS® MEASLES IGG ASSAY KIT. THE CUSTOMER STATED THAT NO PERSONNEL WERE HARMED AS A RESULT OF THE LEAKING VIAL. THE USER WAS REMINDED OF THE PROPER PRECAUTIONS REGARDING PERSONAL PROTECTIVE EQUIPMENT WHEN HANDLING THE VIAL. THOUGH THE ASSOCIATED MSDS INDICATES "NO DANGEROUS REACTION KNOWN UNDER CONDITIONS OF NORMAL USE", IT ALSO STATES PRODUCTS CONTAINED WITHIN THE KIT CAN CAUSE SERIOUS EYE DAMAGE/IRRITATION. THE PACKAGE INSERT FOR THE PRODUCT STATES "WIPE UP SPILLS THOROUGHLY AFTER TREATMENT WITH LIQUID DETERGENT AND A SOLUTION OF HOUSEHOLD BLEACH CONTAINING AT LEAST 0.5% SODIUM HYPOCHLORITE (10% BLEACH) TO INACTIVATE INFECTIOUS AGENTS. EVALUATION OF COMPLAINT RECORDS INDICATES NO OTHER REPORTS OF LEAKING VIDAS® MEASLES IGG CONTROL VIALS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718431 VIDAS® MEASLES IGG ASSAY VIDAS® MEASLES IGG ASSAY LJB BIOMERIEUX SA 1004735420

    Patients

    Seq Age Sex Outcome Treatment
    1