BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® BRAHMS PROCALCITONIN

    MDR report key: 8317462 · Received February 7, 2019

    Report

    Report Number
    8020790-2019-00008
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    September 3, 2018
    Report Date
    April 1, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    NTM
    UDI-DI
    03573026223601
    PMA / PMN Number
    K071146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CAP SURVEY SAMPLE (1374401-01) THAT WAS OUT OF RANGE LOW (1.49NG/ML) COMPARED TO THE ACCEPTABLE RANGE (1.56 - 2.30NG/ML) FOR THE VIDAS BRAHMS PROCALCITONIN (PCT) ASSAY. ** QUALITY CONTROL RECORDS** NO CAPA NOR NON-CONFORMITY WAS LINKED TO THE CUSTOMER'S ISSUE FOR VIDAS PCT, REF. 30450-01, LOT NUMBER 1006455600. ** BATCH HISTORY RECORD** NO ANOMALY DURING THE MANUFACTURING , CONTROL AND PACKAGING PROCESSES ** STUDY OF INTERNAL SAMPLES CONTROL CHARTS ** : FOUR INTERNAL SERA WERE TESTED ON FIVE BATCHES OF VIDAS PCT INCLUDING THE ONE OF THE CUSTOMER. ALL RESULTS ARE WITHIN SPECIFICATIONS. THE CUSTOMER'S LOT WAS IN THE TREND OF THE OTHER LOTS. **COMPLAINT ANALYSIS** NO OTHER SIMILAR COMPLAINT WAS RECORDED FOR AN UNDERESTIMATED RESULT WITH THIS EQA PROGRAM (CAP). **TESTS PERFORMED INTERNALLY ** (1 NG/ML = 1 ¿G/L) CAP SURVEY PCT-B 2018 CAMPAIGN AUG 2018: 604 LABORATORIES USING VIDAS GAVE A RESULT FOR SAMPLE PCT-06 CAP SURVEY COMPLAINT LABORATORY RESULTS : PCT-06 SAMPLE VIDAS PCT LOT 190326-0: 2.02 [?]G / L VIDAS PEER GROUP AVERAGE 1,929 [?]G / L - (MIN AT 1,56 [?]G / L -MAX AT 2,28 [?]G / L) FEB 2019 INVESTIGATION : CAP SURVEY PCT-06 THAWED SAMPLE: VIDAS PCT TESTED WITH PCT LOT 190412-0 : 1.84 [?]G / L VALUE CLOSE TO THE TARGET AND CONFORMS TO THE VIDAS PEER GROUP ACCEPTABLE RANGES. FEB 2019 COMPLEMENTARY TESTS ON INTERNAL SAMPLE PA112 FROM ACTIVITY PANEL: PA112: 3.71 [?]G / L ACCEPTABLE RANGE [3.39-5.33] [?]G / L RELEASE VALUE 4.02 [?]G / L PA112 CONFORMS AND CIS LOSE TO THE VALUE OBTAINED DURING THE ACTIVITY CHECK CONCLUSION THE CUSTOMER'S ANOMALY WAS NOT REPRODUCED. SAMPLE CAP SURVEY PCT-06 WAS TESTED IN AUG 2018 (LOT 190326-0) AND CHECKED IN FEB 2019 ON THE CUSTOMER'S BATCH (VIDAS PCT LOT 1006455600 / 190412-0). BOTH RESULTS ARE CLOSE TO THE TARGET AND CONFORM TO VIDAS PEER GROUP ACCEPTABLE RANGES. ACCORDING TO THE INFORMATION/DATA MENTIONED ABOVE, THE KIT VIDAS PCT LOT 1006455600 / 190412-0 IS WITHIN THE EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A (B)(6) SAMPLE OUT OF RANGE (RESULT WAS 1.49NG/ML, ACCEPTABLE RANGE 1.56 - 2.30NG/ML) FOR THE VIDAS BRAHMS PROCALCITONIN (PCT) ASSAY. REPEAT TESTING OBTAINED RESULTS OF 1.42 AND 1.30 NG/ML. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT ASSOCIATED WITH THE CAP SURVEY SAMPLE. BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106796 VIDAS® BRAHMS PROCALCITONIN VIDAS® BRAHMS PCT NTM BIOMERIEUX SA 1006455600 03573026223601

    Patients

    Seq Age Sex Outcome Treatment
    1