BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® 3

    MDR report key: 13552538 · Received February 17, 2022

    Report

    Report Number
    9615037-2022-00002
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Report Date
    February 17, 2022
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JJE
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: PROBLEM CONFIRMATION: ON 19-JAN-2022 A FSE WAS DISPATCHED IN ORDER TO REPAIR AND QUALIFY THE INSTRUMENT. THE FSE INVESTIGATED THE ISSUE AT CUSTOMER SITE. HE FOUND THE PIPETTOR BLOCKED ON A STRIP. THE STRIP WAS NOT WELL INSERTED IN THE TRAY POSITION. DUE TO THIS BAD INSERTION THE PIPETTOR WAS BLOCKED AND THE BELT WENT OUT OF ITS MOUNT. ACCORDING TO THE LAB MANAGER THE REASON OF THIS ISSUE COULD HAVE BEEN THE INCORRECT STRIP INSERTION IN THE TRAY BY A NEW EMPLOYEE. DETAILED RESULTS OF THE INVESTIGATION: ACCORDING TO THE SERVICE APPOINTMENT, THE FSE PERFORMED SEVERAL ACTIONS ON SITE : - UNLOCKED THE PIPETTOR - REMOVED THE WRONGLY INSERTED STRIP - PUT THE BELT BACK ON THE MOUNT - CHECKED THE TEACHING POSITION AFTER THE INTERVENTION, THE SYSTEM WAS OPERATING PER MANUFACTURING SPECIFICATIONS. CONCLUSION: ACCORDING TO THE INVESTIGATION, THE ROOT CAUSE OF THE ISSUE WAS THE BAD INSERTION OF A STRIP IN THE TRAY WHICH CAUSED THE BLOCKAGE ON THE PIPETTOR. THIS ISSUE HAS BEEN DETERMINED TO BE CAUSED BY AN OPERATOR ERROR.

    Description of Event or Problem · 0

    INTENDED USE: THE VIDAS® 3 SYSTEM IS A COMPLETE STANDALONE IMMUNODIAGNOSTIC SYSTEM INTENDED FOR TRAINED AND QUALIFIED LABORATORY TECHNICIANS (DAILY ROUTINE USE) AND LABORATORY ADMINSTRATORS (APPLICATION CONFIGURATION). THE VIDAS® 3 SYSTEM IS NOT INTENDED TO BE USED WITH INDUSTRY VIDAS® REAGENTS. VIDAS® D-DIMER EXCLUSION II¿ IS AN AUTOMATED QUANTITATIVE TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS® FAMILY FOR THE IMMUNOENZYMATIC DETERMINATION OF FIBRIN DEGRADATION PRODUCTS (FBDP) IN HUMAN PLASMA (SODIUM CITRATE) USING THE ELFA TECHNIQUE (ENZYME LINKED FLUORESCENT ASSAY). VIDAS® D-DIMER EXCLUSION II¿ IS INDICATED FOR USE IN CONJUNCTION WITH A CLINICAL PRETEST PROBABILITY ASSESSMENT MODEL TO EXCLUDE DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) DISEASE IN OUTPATIENTS SUSPECTED OF DVT OR PE. VIDAS® D-DIMER EXCLUSION II¿ IS INDICATED FOR USE IN THE HERDOO2 CLINICAL DECISION RULE (CDR) TO ASSESS THE RISK OF RECURRENCE OF VENOUS THROMBOEMBOLISM (VTE) IN WOMEN WITH A FIRST UNPROVOKED VTE. RISK STRATIFICATION BY THIS CDR IS AN AID TO GUIDE THE DURATION OF ORAL ANTICOAGULANT THERAPY. DESCRIPTION OF THE ISSUE: ON 18-JAN-2022, A CUSTOMER IN POLAND NOTIFIED BIOMÉRIEUX OF BLOCKED INSTRUMENT LEADING TO DELAYED RESULTS WHEN USING THE VIDAS® 3 [U] (REF. 412590U, SERIAL NUMBER: (B)(4) WITH PATIENT SAMPLES. THE ISSUE HAPPENED WHILE PERFORMING VIDAS® D DIMER (REF. 30455) TESTS. THERE WAS AN ERROR WITH THE INSTRUMENT: INCORRECT PIPETTOR MOVEMENT: X AXIS. IT WAS NOT POSSIBLE TO SWITCH TO MANUAL MODE; THEREFORE, USE OF THE INSTRUMENT WAS COMPLETELY BLOCKED. THE CUSTOMER CLAIMED A DELAY OF TWO HOURS IN RENDERING THE RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. UPDATE ON THE 01-FEB-2022, A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) HAS BEEN TO THE CUSTOMER SITE TO ASSESS THE INSTRUMENT AND HAS RESOLVED THIS ISSUE. THE CLIENT SPECIFIED THAT THE DELAY IMPACTED THREE (3) SAMPLES. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862145 VIDAS® 3 VIDAS® 3 JJE BIOMÉRIEUX SA 412590U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown