BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE BNP TEST FOR BECKMAN COULTER

    MDR report key: 3943571 · Received April 30, 2014

    Report

    Report Number
    2027969-2014-00393
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K052789
    Removal / Correction Number
    2027969-03/20/14-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA 14-009 WAS INITIATED DUE TO AN INCREASE IN BIO-RAD AND OTHER THIRD PARTY CONTROL COMPLAINTS OF LOT TO LOT PATIENT SAMPLE BIAS ASSOCIATED WITH TWO AFFECTED BECKMAN TRIAGE BNP FOR BCI REAGENT PACK LOTS. THE ROOT CAUSE WAS DUE TO A NEW GOAT ANTI-BIOTIN ANTIBODY POOL WHICH CAUSED PATIENT SAMPLES AND SPECIFIC COMMERCIALLY AVAILABLE THIRD PARTY CONTROLS TO RECOVER DIFFERENTLY COMPARED TO PREVIOUSLY RELEASED REAGENT LOTS. THE QC TESTING PROCESS AND SAMPLES USED DID NOT DETECT THESE DIFFERENCES BECAUSE THEY PERFORMED DIFFERENTLY LOT TO LOT THAN PATIENT SAMPLES AND SPECIFIC ADDITIONAL COMMERCIAL CONTROLS. ACTIONS INVOLVED DISCONTINUING THE PURIFIED LOT OF GOAT ANTI-BIOTIN USED IN THE AFFECTED LOTS AND QUALIFYING A NEW LOT. IN ADDITION, PATIENT SAMPLE CORRELATION SET TESTING USED FOR THE QUALIFICATION OF THE NEW GOAT ANTI-BIOTIN WILL BE IMPLEMENTED AS PART OF THE RELEASED TESTING OF SUBSEQUENT REAGENT LOTS. COMPLAINT RATES WERE MONITORED FOR OVER 6 MONTHS WITH SIGNIFICANTLY REDUCED RATES, THEREFORE, THE CAPA WAS DEEMED EFFECTIVE AND CLOSED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS ONE LOT OF BNP GIVING LOWER PATIENT RESULTS VERSUS PRIOR LOT (21% DIFFERENCE). CUSTOMER STATES THEIR QC DROPPED AS WELL BUT WAS STILL WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258587 TRIAGE BNP TEST FOR BECKMAN COULTER B-TYPE NATRIURETIC PEPTIDE TEST NBC ALERE SAN DIEGO, INC. 98200 331265

    Patients

    Seq Age Sex Outcome Treatment
    1 USING BIO-RAD CONTROLS.