BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® ANALYZER

    MDR report key: 11930124 · Received June 3, 2021

    Report

    Report Number
    9615037-2021-00005
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    February 2, 2022
    Manufacturer
    BIOMERIEUX ITALIA S.P.A.
    Product Code
    JJE
    UDI-DI
    03573026140427
    PMA / PMN Number
    K891385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE ¿DEW¿ WAS ASSIGNED TO THE REGISTRATION K891385 FOR THE VIDAS® ANALYZER. THIS SUBMISSION IS TO CORRECT THE PRODUCT CODE ¿DEW' AND UPDATE TO THE APPROPRIATE CODE 'JJE' PER FDA REQUEST.

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS COMPLETED FOLLOWING NOTIFICATION FROM OF A QCV ALERT ON POSITION D1 ON THE VIDAS® INSTRUMENT (SERIAL NUMBER : (B)(6)). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED IN ORDER TO REPAIR AND QUALIFY THE INSTRUMENT ON 07-MAY-2021. BETWEEN THE CUSTOMER CONTACT AND THE FSE INTERVENTION, THE CUSTOMER DID NOT USE THE SECTION. REGARDING QCV ALERT, RESULT DETAILS: QCV RUN DATE: 07-MAY-2021. QCV LOT NUMBER USED: 211223-0, EXPIRY DATE: 12-23-2021. FOR THIS QCV LOT NUMBER, TV1 VALUE MUST BE HIGHER THAN 5.7 AND THE R3 VALUE MUST BE HIGHER THAN 4100. ON FAILED POSITION D1, TV1 VALUE : 1.61. FIRST QCV RESULTS ARE OUT OF THE ALLOWED RANGE DUE TO A TV1 FAILURE, ALL OTHER VALUES ARE IN THE ALLOWED RANGE. LAST PREVENTIVE MAINTENANCE WAS PERFORMED ON : 24-JUN-2020 THE CUSTOMER PERFORMS QCV WEEKLY. 2-PROBLEM CONFIRMATION. AN FSE WAS DISPATCHED IN ORDER TO REPAIR AND QUALIFY THE INSTRUMENT ON 07-MAY-2021. THE FSE INVESTIGATED THE ISSUE AT THE CUSTOMER SITE. A QCV FAILURE IS NOT AN ABNORMAL BEHAVIOR. IT MEANS THAT THE QCV PLAYED ITS ROLE AS A FUNCTIONAL CONTROL. THIS CONTROL IS MEANT TO DETECT RESIDUAL RISKS, THAT ARE RARE AND SUDDEN. THOSE RISKS ARE ALREADY PRESENT AND ACCEPTED INTO THE SYSTEM RISK ANALYSIS. 3-DETAILED RESULTS OF THE INVESTIGATION. THE FSE PERFORMED SEVERAL ACTIONS: SECTION VISUAL INSPECTION; PUMP SEALS REPLACEMENT AFTER VISUAL INSPECTION; VISUAL INSPECTION (ON THE TRAY, ON THE DOOR, ON THE SHIELD INSULATE PLATE, ON THE FRAME BOTTOM ); CHECK DOOR PLUNGER BALL. CHECK STRICKER PLATE. CHECK SPRING INTEGRITY. CHECK FREE AND SMOOTH VERTICAL MOVEMENT OF SPR BLOCKS. CHECK SPR BLOCK ALIGNMENT. CHECK TOWER HEIGHT. CHECK TRAY DEPTH. CHECK PUMP BLOCK (MOVEMENT, PUMP SENSOR¿) AFTER ALL THE PREVIOUSLY NOTED CHECKS, THE FSE REPLACED THE SPR BLOCK AND THE PUMP ASSEMBLY. THEN FSE CHECKED FOR PRESENCE OF LEAKS AND PERFORMED THE SYSTEM QUALIFICATION. 4-CONCLUSION. QCV FAILURE ROOT CAUSE WAS A PUMP ASSEMBLY FAILURE. ACTION TO SOLVE THE ISSUE : PUMP REPLACEMENT AND SPR BLOCK REPLACEMENT. FOLLOWING FSE INTERVENTION, THE SYSTEM WAS OPERATING PER MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    PRODUCT DESCRIPTION: THE VIDAS¿ SYSTEM IS AN IMMUNODIAGNOSTIC SYSTEM INTENDED TO BE USED BY TRAINED AND QUALIFIED LABORATORY PROFESSIONALS, FOR IN VITRO DIAGNOSTIC (IVD) PURPOSE, VETERINARY AND INDUSTRIAL APPLICATIONS. THE VIDAS¿ SYSTEM IS INTENDED TO EXECUTE AN IMMUNOASSAY PROTOCOL AND TO RELEASE RESULTS ACCORDING TO THE PACKAGE INSERT OF THE VIDAS¿ ASSAY KITS. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM (B)(6) REPORTED QCV FAILURE THAT LEAD TO (B)(6) RESULTS DURING PATIENT SAMPLE TESTING WITH VIDAS (B)(6) AND HBS KITS. INDEED, TWO (B)(6) RESULTS IN (B)(6) AND ONE IN (B)(6) WERE FOUND IN THE PERIOD FROM (B)(6) 2021 WHICH WAS THE PERIOD BETWEEN THE LAST VALID QCV AND THE FIRST INVALID QCV. THE NUMBER OF PATIENTS IMPACTED BY THE DISCREPANT RESULTS WAS NOT SPECIFIED. THE CUSTOMER SPECIFIED THAT THE POSITIVE RESULTS ARE NEVER GIVEN TO THE PATIENT WITHOUT BEING CONFIRMED BY ANOTHER TECHNIQUE. THE CUSTOMER STATED THAT NO OTHER INVALID RESULTS WERE OBTAINED OR DELAYED RESULTS THAT WOULD COMPROMISE PATIENTS. A BIOMRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829049 VIDAS® ANALYZER VIDAS® ANALYZER JJE BIOMERIEUX ITALIA S.P.A. 99735 03573026140427
    829050 VIDAS® ANALYZER VIDAS® ANALYZER JJE BIOMERIEUX ITALIA S.P.A. 99735 03573026140427

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown