BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® BRAHAMS PROCALCITONIN

    MDR report key: 9298662 · Received November 8, 2019

    Report

    Report Number
    8020790-2019-00066
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Report Date
    January 18, 2022
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PRI
    PMA / PMN Number
    K162827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN SOUTH AFRICA REGARDING FALSE LOW PCT RESULTS FOR A PATIENT SAMPLE ASSOCIATED WITH THE VIDAS® BRAHMS PROCALCITONIN 60T TEST KIT (REFERENCE 30450, LOT 1007294400). THE CUSTOMER STATED THE PATIENT SAMPLE WAS RETESTED FOLLOWING A QCV DETECTED FAILURE IN SECTION A OF THE VIDAS® INSTRUMENT. THE ORIGINAL RESULT WAS 8.43NG/ML, THE RETEST YIELDED A RESULT OF <0.05NG/ML. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR TESTING AND OBTAINED A RESULT OF 8.43NG/ML. REFERENCE 30450 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30450-01. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: INVESTIGATION RESULTS CUSTOMER'S MATERIAL THE CUSTOMER'S SAMPLES WERE NOT RETURNED. BATCH HISTORY RECORDS AND TREND ANALYSIS NO NON-CONFORMITY AND NO CAPA LINKED TO THE CUSTOMER'S COMPLAINT RECORDED ON VIDAS BRAHMS PROCALCITONIN REF 30450 LOT 1007294400. THE BATCH HISTORY RECORDS SHOWS NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. **STUDY OF INTERNAL SAMPLES CONTROL CHARTS** ANALYSIS OF FOUR (4) INTERNAL SERA FROM ADJUSTMENT PANEL: PA121 [0.06 - 0.18] NG/ML TARGET 0.12 NG/ML PA102 [0.27 - 0.51] NG/ML TARGET 0.39 NG/ML PA118 [6.02 - 9.42] NG/ML TARGET 7.72 NG/ML PA116 [8.33 - 13] NG/ML TARGET 10.7 NG/ML THIS ANALYSIS WAS CARRIED OUT ON SEVEN (7) LOTS OF VIDAS PCT INCLUDING THE CUSTOMER'S LOT : 1007294400. ALL THE RESULTS WERE WITHIN SPECIFICATIONS AND THE CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER LOTS. CONCLUSION: THERE WAS NO ANOMALY HIGHLIGHTED WITH THE CONTROL CHART AND THE ANALYSIS OF QUALITY DATA PERFORMED ON THE LOT VIDAS BRAHMS PROCALCITONIN REF 30450 1007294400. VIDAS PCT LOT 1007294400 IS WITHIN ITS SPECIFICATIONS. PERFORMANCES OF VIDAS PCT 1007294400 / 200726-0 ARE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF FALSE LOW PCT RESULTS FOR A PATIENT SAMPLE ASSOCIATED WITH THE VIDAS® BRAHMS PROCALCITONIN 60T TEST KIT (REFERENCE 30450, LOT 1007294400). THE CUSTOMER STATED THE PATIENT SAMPLE WAS RETESTED FOLLOWING A QCV DETECTED FAILURE IN SECTION A OF THE VIDAS® INSTRUMENT. THE ORIGINAL RESULT WAS 8.43NG/ML, THE RETEST YIELDED A RESULT OF <0.05NG/ML. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR TESTING AND OBTAINED A RESULT OF 8.43NG/ML. THERE IS NO PATIENT IMPACT, THE CUSTOMER CONFIRMED THE RESULT OF 8.43NG/ML WAS REPORTED TO THE TREATING PHYSICIAN. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION. REFERENCE 30450 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094654 VIDAS® BRAHAMS PROCALCITONIN VIDAS® BRAHAMS PCT PRI BIOMERIEUX SA 1007294400

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown