BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGA-2

    MDR report key: 14269793 · Received May 3, 2022

    Report

    Report Number
    1823260-2022-01254
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CZP
    UDI-DI
    07613336121313
    PMA / PMN Number
    K040435
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NA.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD D4, LOT NUMBER HAS BEEN UPDATED.FOR THE SAMPLE MEASUREMENTS OF 0.167 G/L ON 11-APR-2022 AND 0.77 G/L ON (B)(6) 2022, THE CUSTOMER IS FAIRLY CONFIDENT THESE RESULTS WERE ALSO MEASURED WITH A PROGRAMMED DILUTION ON THE ANALYZER. THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION AND THE RESULTS OBTAINED BY THE CUSTOMER COULD BE REPRODUCED. THE RESULTS SHOWED A VERY HIGH CONCENTRATION OF IGA IN THE PATIENT SAMPLE. A CLEAR RESULT COULD NOT BE OBTAINED AS ALL VALUES SHOWED FLAGS INDICATING THE ABSORBANCE WAS HIGHER THAN THE TECHNICAL LIMIT OF THE ASSAY. THE CAUSE OF THE INCORRECTLY LOW MEASURED RESULTS IN CUSTOMERS LAB WITHOUT A FLAG IS CONSISTENT WITH A HANDLING ERROR DURING THE REPEAT MEASUREMENT. DILUTIONS PERFORMED ON THE ANALYZER OUTSIDE OF THE DECREASED MODE HAVE TO BE PERFORMED MANUALLY, AS THE DEFAULT PRE-DILUTION FOR THE IGA APPLICATION IS CANCELLED AND AN INCORRECT /INVALID RESULT IS MEASURED.PER PRODUCT LABELING: "TO MEASURE THE SAMPLE WITH A SPECIFIC DILUTION, CHOOSE THE DILUTION FROM THE DROP-DOWN LIST ON THE TEST KEY. A MANUAL SELECTION OVERWRITES THE PREPROGRAMMED DILUTION RATIO INDICATED ON MENU > APPLICATION > ANALYTICAL PARAMETERS. IF THE TEST HAS A PRE-PROGRAMMED DILUTION RATIO OF 1:5, FOR EXAMPLE, AND YOU SELECT 1:2, THE TEST IS PROCESSED WITH A DILUTION RATIO OF 1:2."THE PRODUCT IS WORKING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH IGA-2 TINA-QUANT IGA GEN.2 ON A COBAS PRO C 503 ANALYZER (SERIAL NUMBER (B)(4)). A QUESTIONABLE VALUE FROM THE SAMPLE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE VALUES DID NOT CORRESPOND TO OTHER LABORATORY FINDINGS OF THE PATIENT AND A HIGH DOSE HOOK EFFECT WAS SUSPECTED. THE SAMPLE WAS INITIALLY TESTED TWICE AND DID NOT GENERATE IGA VALUES, ONLY DATA FLAGS. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 0.167 G/L. THE SAMPLE WAS DILUTED 1:3 BY THE ANALYZER AND REPEATED, RESULTING IN A VALUE OF 0.0758 G/L. THE SAMPLE WAS REPEATED ON (B)(6) 2022, RESULTING IN A VALUE OF 0.77 G/L. THE 0.77 G/L VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO MEDICAL PERSONNEL. OTHER LABORATORY FINDINGS OF THE PATIENT INCLUDE A TOTAL PROTEIN RESULT OF 128 G/L AND AN IGA "M GRADIENT" ELECTROPHORESIS RESULT (CALCULATED IGA) OF 80 G/L. IMMUNOFIXATION OF THE PATIENT SAMPLE CONFIRMED THE PRESENCE OF IGA LAMBDA. REFER TO THE ATTACHMENT FOR ELECTROPHORESIS AND IMMUNOFIXATION RESULTS. BASED ON THESE FINDINGS, MULTIPLE MYELOMA TYPE IGA LAMBDA OF THE PATIENT IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762725 IGA-2 IMMUNOGLOBULIN A CZP ROCHE DIAGNOSTICS NA 562161 07613336121313

    Patients

    Seq Age Sex Outcome Treatment
    1 Male