BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS LYME IGM

    MDR report key: 10785278 · Received November 4, 2020

    Report

    Report Number
    8020790-2020-00117
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Report Date
    December 23, 2020
    Product Code
    LSR
    PMA / PMN Number
    K122979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN FRANCE REGARDING UNDERESTIMATED RESULTS IN ASSOCIATION WITH THE VIDAS® LYME IGM TEST KIT (REF. (B)(4), LOT 1008136160) WHEN TESTING EXTERNAL QUALITY CONTROL ACCURUN 312 SAMPLE. THE CUSTOMER STATED THE EXPECTED RANGE OF THE EXTERNAL QUALITY CONTROL ACCURUN 312 SAMPLE WAS 0.47 - 0.55 INTERPRETED AS POSITIVE. THE ANALYSIS OF THE QUALITY CONTROL CHARTS FOR VIDAS® LYME IGM LOT 1008136160/210605-0 SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, AND PACKAGING PROCESSES IN RELATION WITH THE COMPLAINT. AN ANALYSIS OF THE CONTROL CHARTS OF FIVE (5) INTERNAL SAMPLES AND SEVEN (7) VIDAS® LYME IGM BATCHES INCLUDING THE CUSTOMER¿S LOT 1008136160/210605-0 WAS PERFORMED. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER¿S LOT WAS IN THE TREND OF THE OTHER IGM LOTS. THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES ON THE RETAIN KIT VIDAS® LYME IGM LOT 1008136160/210605-0. ALL OF THE RESULTS WERE WITHIN ACCEPTABLE RANGES WITHOUT CHANGE OF INTERPRETATION, AND WERE CLOSE TO THOSE OBTAINED BEFORE THE BATCH RELEASE. THE LAB DID NOT OBSERVE ANY EVOLUTION OVER TIME SINCE THE BATCH RELEASE. THE SAMPLES RETURNED BY THE CUSTOMER, ACCURUN 132 AND ONE (1) PATIENT SAMPLE, WERE TESTED ON THE RETAIN OF VIDAS® LYM LOT 1008136160/210605-0 AND A PREVIOUS LOT USED BY THE CUSTOMER VIDAS® LYME IGM 210105-0. THE COMPLAINT LABORATORY CONFIRMED A LOWER RESULT WITH THE RETAIN OF THE CUSTOMER¿S LOT COMPARED TO THE PREVIOUS LOT USED BY THE CUSTOMER, BUT WITHOUT CHANGE OF INTERPRETATION. AS A RESULT OF THE INVESTIGATION, NO ANOMALIES WERE HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE QUALITY DATA ANALYSIS, OR THE TESTS PERFORMED. THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® LYME IGM LOT 1008136160/210605-0. HOWEVER, LIKE THE CUSTOMER, WE OBSERVED AN INTER-LOT VARIABILITY, BUT WITHIN PRODUCT SPECIFICATION.SEE SECTION H10.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF UNDERESTIMATED RESULTS IN ASSOCIATION WITH THE VIDAS® LYME IGM TEST KIT (REF. 30319, LOT 1008136160) WHEN TESTING EXTERNAL QUALITY CONTROL ACCURUN 312 SAMPLE. THE CUSTOMER STATED THE EXPECTED RANGE OF THE EXTERNAL QUALITY CONTROL ACCURUN 312 SAMPLE WAS 0.47 - 0.55 INTERPRETED AS POSITIVE. THE CUSTOMER TESTED THE EXTERNAL QUALITY CONTROL ACCURUN 312 TWICE REPORTED THAT THEY PERFORMED TESTS ON THE LOT 1008136160 VIDAS LYME IGM (REF. 30319) SINCE (B)(6) 2020 AND THEY OBSERVED LOWER VALUES WITH THE EXTERNAL QUALITY CONTROL ACCURUN 312. THE RANGE ESTABLISHED RANGE BY THE CUSTOMER FOR THE ACCURUN 312 SAMPLE WAS 0.47 - 0.55. ON (B)(6) 2020, THE CUSTOMER OBTAINED THREE OUT OF RANGE LOW VALUES (0.46 ¿ 0.45 ¿ 0.44). SINCE (B)(6) 2020, THE CUSTOMER OBTAINED OUT OF RANGE LOW VALUES (0.34 ¿ 0.39 ¿ 0.4 ¿ 0.37 ¿ 0.37 ¿ 0.33 ¿ 0.41). THE CUSTOMER PERFORMED NEW CALIBRATION AND AGAIN RETESTED THE ACCURUN 312 SAMPLE; A POSITIVE RESULT OF 0.36 WAS OBTAINED. ALL RESULTS OBTAINED BY THE CUSTOMER FOR THE ACCURUN 312 WERE UNDER THE EXPECTED RANGE; HOWEVER, ALL TESTS OBTAINED THE CORRECT CLINICAL INTERPRETATION OF POSITIVE. BASED UPON THE UNDERESTIMATED RESULTS OBTAINED FOR THE EXTERNAL ACCURUN 312 SAMPLE, THE CUSTOMER IDENTIFIED THREE PATIENT SAMPLES WERE TESTED WITH LOT 1008136160. ONE SAMPLE WAS RETESTED; THE RETEST RESULT OBTAINED THE SAME POSITIVE CLINICAL INTERPRETATION. THE TWO OTHER PATIENT SAMPLES, PATIENT A AND PATIENT B, OBTAINED RESULTS OF EQUIVOCAL AND NEGATIVE RESPECTIVELY. ADDITIONAL TESTING WAS PERFORMED AND ALIGNED WITH THE VIDAS® LYME IGM RESULTS. DETAILS ARE AS FOLLOWS: PATIENT A: VIDAS: 740 RFV 0.26 EQUIVOCAL, EUROIMMUN AC IGM NEGATIVE 9UR / ML (CUT OFF 16UR / ML), ENZYGNOST AC IGG NEGATIVE <7U / ML. PATIENT B: VIDAS: 383 RFV 0.13 NEGATIVE, EUROIMMUN AC IGM LIMIT 19UR / ML (CUT OFF 16UR / ML ), ENZYGNOST AC IGG NEGATIVE <7U / ML, IMMUNOBLOT (EUROLINE RN-AT) AC ANTI-OSPC DOUBTFUL 13. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL SAMPLE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252756 VIDAS LYME IGM VIDAS® LYME IGM LSR 1008136160

    Patients

    Seq Age Sex Outcome Treatment
    1