BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT TSH REAGENT KIT

    MDR report key: 16674478 · Received April 4, 2023

    Report

    Report Number
    3005094123-2023-00086
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    March 13, 2023
    Report Date
    May 18, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    UDI-DI
    00380740014247
    PMA / PMN Number
    K983442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ARCHITECT TSH REAGENT LOT 48544UD00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. INHOUSE TESTING OF REAGENT LOT 48544UD00 DETERMINED THAT THE ACCURACY PERFORMANCE IS NOT NEGATIVELY IMPACTED. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON OUR INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ARCHITECT TSH REAGENT LOT 48544UD00 WAS IDENTIFIED. SEE MFR# SEE MFR# 3005094123-2023-00089-00 FOR THE OTHER LOT# SUBMISSION.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SEE MFR# SEE MFR# 3005094123-2023-00089-00 FOR THE OTHER LOT# SUBMISSIONSECTION B1 AND B2 UPDATED SECTION B5 UPDATED WITH ADDITIONAL INFORMATION/DATA SECTION H1 UPDATED TO SERIOUS INJURY SECTION H6. CHANGED HEALTH EFFECT IMPACT CODE TO F05

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) SID (B)(6) (LOT# 48544UD00) = 4.58, 1:10 DILUTION = 15.092 / 11.934 UIU/ML, COBAS = 18.2 NO UOM PROVIDED. NORMAL RANGE: (0.35-4.95 UIU/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PRETERM NEWBORN PATIENT. RESULTS PROVIDED: (B)(6) 2023 SID (B)(6) ON LOT# (47474UD00) = 7.016, 1:10 DILUTION = 14.5 UIU/ML, COBAS = 18.62 (NO UOM PROVIDED). NEW SAMPLE, SAME PATIENT (B)(6) 2023 SID (B)(6) (LOT# 48544UD00) = 4.58, 1:10 DILUTION = 15.092 / 11.934 UIU/ML, COBAS = 18.2 (NO UOM PROVIDED).THE NEONATAL PRETERM INFANT WITH DOWN SYNDROME HAD A DELAY IN THYROID TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TSH RESULT ON A PRETERM NEWBORN PATIENT. RESULTS PROVIDED: (B)(6) 2023 SID (B)(6) ON LOT# (47474UD00) = 7.016, 1:10 DILUTION = 14.5 UIU/ML, COBAS = 18.62 (NO UOM PROVIDED). NEW SAMPLE, SAME PATIENT (B)(6) 2023 SID (B)(6) (LOT# 48544UD00) = 4.58, 1:10 DILUTION = 15.092 / 11.934 UIU/ML, COBAS = 18.2 (NO UOM PROVIDED). THE NEONATAL PRETERM INFANT WITH DOWN SYNDROME HAD A DELAY IN THYROID TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392745 ARCHITECT TSH REAGENT KIT RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 7K62-30 48544UD00 00380740014247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other ARC I2000SR INST, 03M74-02, ISR50611| ARC I2000SR INST, 03M74-02, ISR50611| ARC I2000SR INST, 03M74-02, ISR50611