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

Catalog Number	07026919190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable thyroid assay results for two samples collected from the same patient tested on a cobas 8000 e 801 module.Results from the following assays were affected: elecsys t3, the elecsys t4 assay, elecsys ft3 iii, the elecsys ft4 assay, roche diagnostics elecsys anti-tg, and roche diagnostics cobas elecsys anti-tpo.The thyroid results were not consistent with the patient's clinical situation.All results were reported outside of the laboratory to the doctor and patient.This medwatch will apply to the anti-tg assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the t3 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the t4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the anti-tpo assay.Refer to the attachment for all patient data.The sample from (b)(6) 2022 was repeated on (b)(6) 2022.An experiment was also performed with the sample from (b)(6) 2022 by centrifuging the sample, removing the supernatant, and incubating the sample with 1 or 2 ml.Of reagent microparticle beads.The serial number of the e 801 analyzer is (b)(4).
Additional Manufacturer Narrative
Na.
Additional Manufacturer Narrative
A third sample was collected from the patient and tested on 10-nov-2022.Please see the attachment for all patient data.The sample was tested on the e 801 analyzer.An experiment was also performed with the sample by centrifuging the sample, removing the supernatant, and incubating the sample with 2 ml.Of reagent microparticle beads.
Additional Manufacturer Narrative
A sample from the patient was provided for investigation.Investigations of the sample determined that it contains an interfering factor against the streptavidin component of the roche assay.Per product labeling: "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.".

• Brand Name: ELECSYS ANTI-TG
• Common Device Name: THYROID AUTOANTIBODY TEST SYSTEM
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15726132
• Report Number: 1823260-2022-03480
• Device Sequence Number: 2872368
• Product Code: JZO
• UDI-Device Identifier: 04015630939619
• UDI-Public: 04015630939619
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053426
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2023

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 07026919190
• Device Lot Number: 595375
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 12/15/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/23/2022; 01/04/2023
• 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
• Patient Sex: Unknown