MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR V2; THYROID AUTOANTIBODY TEST

Catalog Number	08496633190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's calibration and qc results, sample pre-analytic details, and system alarm trace were requested but not provided.The observed difference in anti-tshr values generated with the elecsys assay and the rra methodology was consistent with differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.Based on the provided information, the investigation did not identify a product problem.
Event or Problem Description
The initial reporter received questionable elecsys anti-tshr v2 results for one patient tested on a cobas 8000 e 801 module.The e 801 module serial number was requested but not provided.The patient's initial elecsys anti-tshr result was not reported outside the laboratory.The customer performed repeat testing with the patient's sample with rra methodology.The patient's elecsys anti-tshr result was 1.5 iu/l "negative." the patient's anti-tshr result with rra methodology was 2.3 iu/l "positive.".

• Brand Name: ELECSYS ANTI-TSHR V2
• 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: 12852440
• Report Number: 1823260-2021-03424
• Device Sequence Number: 5156004
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: ASKU
• 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: 11/02/2021
• Initial Report FDA Received Date: 11/22/2021
• 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