BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 10808766 · Received November 9, 2020

    Report

    Report Number
    1823260-2020-02816
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    September 30, 2020
    Report Date
    January 12, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONFIRMED A BIOTIN INTERFERENCE WAS RULED OUT. THE INVESTIGATION VERIFIED THE CUSTOMER'S CALIBRATION DATA WAS ACCEPTABLE. THE PATIENT'S SAMPLE WAS REQUESTED FOR AN INVESTIGATION DUE TO A SUSPECTED INTERFERENCE, BUT THE SAMPLE WAS NOT AVAILABLE. THE INVESTIGATION STATED HETEROPHILIC BLOCKING TUBE (HBT) TESTING WAS NOT A VALIDATED RECOMMENDATION FOR TSH, FT4, AND T4. FOR TSH DILUTION, PRODUCT LABELING STATES "SAMPLES WITH TSH CONCENTRATIONS ABOVE THE MEASURING RANGE CAN BE DILUTED WITH DILUENT MULTIASSAY. THE RECOMMENDED DILUTION IS 1:10 (EITHER AUTOMATICALLY BY THE ANALYZER OR MANUALLY)." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. UPDATED MEDWATCH FIELDS: D1, D2, D4, G1, G4. THE FOLLOWING FIELDS ARE TO BE FILLED IN AS FOLLOWS IN RELATION TO THE FT4 REAGENT: D1 - BRAND NAME: ELECSYS FT4 II ASSAY, D2 - COMMON DEVICE NAME: RADIOIMMUNOASSAY, FREE THYROXINE, D2B - PRODUCT CODE: CEC, D4 - MODEL NUMBER: FT4 G2, D4 - CATALOG NO: 07027397190, D4 - LOT NO: 45434500, D4 - EXPIRATION DATE 30-APR-2021, D4 UNIQUE IDENTIFIER (UDI) #: (B)(4), G4 - PMA/510(K) #: K131244. THE FOLLOWING FIELDS ARE TO BE FILLED IN AS FOLLOWS IN RELATION TO THE T4 REAGENT: D1 - BRAND NAME: ELECSYS T4 ASSAY, D2 - COMMON DEVICE NAME: RADIOIMMUNOASSAY, TOTAL THYROXINE, D2B - PRODUCT CODE: CDX, D4 - MODEL NUMBER: NA, D4 - CATALOG NO: 07027885190, D4 - LOT NO: 44937600, D4 - EXPIRATION DATE 30-APR-2021, D4 UNIQUE IDENTIFIER (UDI) #: (B)(4), G4 - PMA/510(K) #: K961490.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 II ASSAY, ELECSYS T4 ASSAY, AND ELECSYS TSH ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE. THE PATIENT¿S INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT¿S PHYSICIAN QUESTIONED THE INITIAL RESULTS AND THE CUSTOMER PERFORMED FURTHER TESTING FOR CONFIRMATION. THE CUSTOMER PERFORMED ADDITIONAL TESTING ON THE SAME E 801 MODULE, A BECKMAN COULTER DXI 800 ANALYZER, AND A SIEMENS CENTAUR ANALYZER. THE PHYSICIAN DETERMINED THE BECKMAN COULTER RESULTS TO BE CORRECT. TSH REAGENT LOT NUMBER WAS 45429600 WITH AN EXPIRATION DATE REQUESTED BUT NOT PROVIDED. T4 REAGENT LOT NUMBER WAS 44937600 WITH AN EXPIRATION DATE REQUESTED BUT NOT PROVIDED. FT4 REAGENT LOT NUMBER WAS 45434500 WITH AN EXPIRATION DATE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276810 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS TSH 45429601

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR