BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 10429337 · Received August 20, 2020

    Report

    Report Number
    3005094123-2020-00179
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 28, 2020
    Report Date
    January 25, 2021
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    UDI-DI
    00380740014247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSELY DEPRESSED ARCHITECT TSH (THYROID STIMULATING HORMONE) RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. IN HOUSE ACCURACY TESTING OF REAGENT LOT 13216UI00 WAS COMPLETED. TESTING OF THE RETURNED PATIENT SAMPLE WAS COMPLETED. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT NUMBER 13216UI00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. ACCURACY TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A TEST PROTOCOL WAS COMPLETED USING RETURNED PATIENT SAMPLE MATERIAL. THE SAMPLE WAS TREATED USING DILUTION LINEARITY AND HETEROPHILIC BLOCKING TUBE TO TEST FOR POTENTIAL INTERFERENCE. OUR TEST RESULT FOR THE UNDILUTED SAMPLE WAS SIMILAR TO THE VALUES OBSERVED AT CUSTOMER SITE, SAMPLE (B)(6) WAS 0.382UIU/ML. ALL VALUES REMAINED IN THE LOWER NORMAL RANGE AFTER DILUTION (SAMPLE (B)(6) WAS 0.84UIU/ML) AND AFTER TREATMENT WITH HBR TUBES (SAMPLE (B)(6) WAS 0.41 UIU/ML). THE DIFFERENCES OBTAINED AFTER DILUTION AND TESTING WITH HETEROPHILIC ANTIBODY BLOCKING TUBES INDICATES THAT AN INTERFERENT IS PRESENT IN THE PATIENT SAMPLE. HOWEVER, ALL VALUES REMAINED IN THE LOWER NORMAL RANGE AND REVIEW OF ALL PATIENT AND TEST INFORMATION PROVIDED INDICATES THE ARCHITECT RESULTS ARE IN ALIGNMENT. BASED ON THE INVESTIGATION NO SYSTEM ISSUE OR DEFICIENCY OF THE ARCHITECT TSH ASSAY FOR LOT 13216UI00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH (THYROID STIMULATING HORMONE) RESULTS FOR ONE PATIENT. THE RESULTS DONT MATCH CLINICAL PICTURE AND DISCREPANT WITH OTHER METHODS. THE FOLLOWING DATA WAS PROVIDED: FEMALE PATIENT AROUND 40 YEARS OLD: (B)(6) 2020 SID (B)(6) INITIAL RESULT = 0.23 UIU/ML ON SERIAL (B)(6), REPEAT ON ARCHITECT I202729 = 0.22 UIU/ML, REPEAT ON BECKMAN = 2.13 UIU/ML, REPEAT ON ROCHE = 2.53 UIU/ML, ADDITIONAL LABORATORY DATA WAS PROVIDED: ARCHITECT FREE T4 = 9.8 PG/ML, ARCHITECT FREE T3 = 2.9 PG/ML REFERENCE RANGES: ARCHITECT AND BECKMAN = 0.35 TO 4.94 UIU/ML, ROCHE = 0.27 TO 4.2 UIU/ML ADDITIONAL DATA WAS PROVIDE: THE PATIENT HAD A NEW SAMPLE DRAWN THAT GENERATED RESULTS OF 0.36 UIU/ML ON (B)(6) 2020 ON SID (B)(6) . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH (THYROID STIMULATING HORMONE) RESULTS FOR ONE PATIENT. THE RESULTS DON'T MATCH CLINICAL PICTURE AND DISCREPANT WITH OTHER METHODS. THE FOLLOWING DATA WAS PROVIDED: FEMALE PATIENT AROUND (B)(6) YEARS OLD: ON (B)(6) 2020 SID (B)(6) INITIAL RESULT = 0.23 UIU/ML ON SERIAL (B)(4), REPEAT ON ARCHITECT (B)(4) = 0.22 UIU/ML, REPEAT ON BECKMAN = 2.13 UIU/ML, REPEAT ON ROCHE = 2.53 UIU/ML, ADDITIONAL LABORATORY DATA WAS PROVIDED: ARCHITECT FREE T4 = 9.8 PG/ML, ARCHITECT FREE T3 = 2.9 PG/ML. REFERENCE RANGES: ARCHITECT AND BECKMAN = 0.35 TO 4.94 UIU/ML, ROCHE = 0.27 TO 4.2 UIU/ML. ADDITIONAL DATA WAS PROVIDE: THE PATIENT HAD A NEW SAMPLE DRAWN THAT GENERATED RESULTS OF 0.36 UIU/ML ON (B)(6) 2020. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894315 ARCHITECT TSH TSH JLW A.I.D.D LONGFORD 7K62-30 13216UI00 00380740014247

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR ARC PROCESS MOD, 08C89-01, I202673| ARCHITECT I2000SR PROCESSING MODULE| LIST 08C89-01| SERIAL I202673 AND I202729