BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® BRAHAMS PROCALCITONIN

    MDR report key: 8669246 · Received June 4, 2019

    Report

    Report Number
    8020790-2019-00031
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PRI
    UDI-DI
    03573026223601
    PMA / PMN Number
    K071146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE LOW RESULT FOR A CAP SURVEY SAMPLE, USING THE VIDAS® BRAHMS PROCALCITONIN (PCT) ASSAY, LOT: 1006974220. CUSTOMER'S MATERIAL: NO CUSTOMER'S MATERIAL WAS RECEIVED FOR INVESTIGATION. QUALITY CONTROL RECORDS: NO CAPA NOR NON CONFORMITY LINKED TO THE CUSTOMER'S ISSUE WAS RECORDED ON VIDAS BRAHMS PROCALCITONIN REFERENCE: (B)(4), LOT: 1006974220 / 191127-0. ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES ON LOT VIDAS BRAHMS PROCALCITONIN REFERENCE: (B)(4), LOT: 1006974220 / 191127-0. STUDY OF INTERNAL SAMPLES CONTROL CHARTS : COMPLAINT LABORATORY OBSERVED 4 INTERNAL SERA (TARGETS 1.22 G/L ; 7.72 G/L ; 10.7 G/L; 0.30 G/L) ON 9 LOTS OF VIDAS BRAHMS PROCALCITONIN INCLUDING CUSTOMER'S LOT: (191127-0). ALL RESULTS WERE WITHIN SPECIFICATIONS AND THE CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER LOTS. COMPLAINT ANALYSIS : NO OTHER COMPLAINT WAS REGISTERED ON THE SAME EXTERNAL QUALITY CONTROL CAP SURVEY PCT A01. TESTS PERFORMED IN COMPLAINT'S LABORATORY: COMPLAINT LABORATORY TESTED 4 INTERNAL SAMPLES (SAME AS ABOVE) ON RETAIN KIT VIDAS BRAHMS PROCALCITONIN REFERENCE: (B)(4), LOT: 1006974220 / 191127-0. RESULTS WERE WITHIN SPECIFICATIONS AND CLOSE TO THE VALUES OBTAINED BEFORE BATCH RELEASE. THERE WAS NO DRIFT OF THE BATCH SINCE ITS RELEASE. CONCLUSION: CUSTOMER'S ISSUE WAS NOT REPRODUCED. ACCORDING TO ALL THE DATA ABOVE, VIDAS BRAHMS PROCALCITONIN REFERENCE: (B)(4), LOT: 1006974220 / 191127-0 PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED THAT THEY OBTAINED A FALSE LOW RESULT FOR THEIR CAP SURVEY SAMPLE, USING THE VIDAS® BRAHAMS PROCALCITONIN (PCT) ASSAY, LOT 1006974220. THE CUSTOMER STATED THE QC WAS WITHIN RANGE USING KIT CONTROLS. S1 RFV WAS 2077 (RANGE 1748 - 3122; MEAN 2435); S2 RFV 424 (RANGE 292 - 521; MEAN 406.5); C1 18.10 NG/ML (RANGE 12.95 - 20.23NG/ML); C2 1.86 NG/ML (RANGE 1.33 - 2.15 NG/ML); QC RESULT OF 5.64 NG/ML ( EXPECTED VALUE RANGE WAS 6.21 - 8.56 NG/ML). ACCORDING TO THE CAP SURVEY REPORT: PCT-01 : CUSTOMER S RESULT 5.64 NG/ML PEER GROUP MEAN = 7.386 NG/ML RANGE [6.21-8.56] => OUT OF RANGE TOO LOW; PCT-02 : CUSTOMER S RESULT < 0.05 NG/ML NOT EVALUATED; PCT-03 : CUSTOMER S RESULT 1.96 NG/ML PEER GROUP MEAN = 2.240 NG/ML RANGE [1.86-2.67]. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460266 VIDAS® BRAHAMS PROCALCITONIN VIDAS® BRAHAMS PCT PRI BIOMERIEUX SA 1006974220 03573026223601

    Patients

    Seq Age Sex Outcome Treatment
    1