MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY TEST

Catalog Number	08496633190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-tshr results on cobas pro sample supply unit, serial number (b)(4).This medwatch covers the alleged results for the elecsys anti-tshr assay.Please refer to medwatch mdr-65386 for the alleged elecsys ft3 iii assay results.The initial result was 3.6 iu/l.A different sample from the same patient was tested the next day and the result was 2.3 iu/l.The customer repeated the test with other competitor methods.It is unknown if the results are from the initial sample or the second sample.The repeated results were 5.2 iu/l using the malmö method, <0.3 iu/l using the kryptor method, and <1.5 iu/l using the phadia method.The result of <0.3 ui/l was considered to be correct.The results were assessed by a doctor.The date of event is unclear as the customer states they performed testing on (b)(6) 2021, but have the results listed from (b)(6) 2021.
Additional Manufacturer Narrative
The patient was taking supplements containing 50 mg + 75 mg biotin.Product labeling states: "this assay has no biotin interference in serum concentrations up to 600 ng/ml." the investigation is ongoing.
Additional Manufacturer Narrative
Section d4: lot no was updated.
Additional Manufacturer Narrative
The alleged anti-tshr results of 2.3 iu/l (obtained on 06-dec-2021) and 5.2 iu/l (obtained on 05-may-2021) were from separate samples.Please refer to medwatch a1 patient identifier (b)(6) for the alleged elecsys tsh assay results.Refer to attachment "(b)(6).Pdf" for additional patient results.It is unknown if the results are from the same sample.The cobas e 801 analytical unit serial number is (b)(6) and the cobas pro sample supply unit serial number is (b)(6).It is unknown which module the results were obtained on.The customer's calibration and qc results and sample pre-analytic details were requested but not provided.The patient sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Investigation of the patient sample confirmed the customer's results.An interfering factor was detected in the sample.This is a known interference documented in the product labeling for the assay: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.A general product problem can be excluded.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• Brand Name: ELECSYS ANTI-TSHR
• Common Device Name: THYROID AUTOANTIBODY TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13258976
• Report Number: 1823260-2022-00124
• Device Sequence Number: 19222946
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K193313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 08496633190
• Device Lot Number: 521228
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/14/2022; 03/18/2022; 06/07/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/07/2022; 04/13/2022; 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOTIN SUPPLEMENTS; ESTRADOT; MEKOBALAMIN APL; MOLLIPECT; PROVERA
• Patient Sex: Female