MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	E411 RACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer determined the reagent pack was contaminated.The reagent pack was replaced.Calibration and controls were successful.H3: na.
Event or Problem Description
The initial reporter stated they received discrepant results for an unspecified number of patient samples tested with the elecsys tsh assay ver.2 on a cobas e 411 analyzer (rack system).Results will be low and then higher when repeated on a second analyzer.The reporter provided an example of data for one patient sample with discrepant tsh results.The reporter stated they had been having issues with tsh calibration and controls.The sample initially resulted in a tsh value of < 0.005 miu/ml with a data flag and this value was reported outside of the laboratory.The sample was repeated since patient results were recovering low.When repeated on the same analyzer, the tsh result was 2.49 miu/ml.The repeat value was deemed correct.The tsh reagent lot number was 653309.The reagent expiration date was requested, but not provided.
Additional Manufacturer Narrative
The sample repeat value was measured on a second instrument.
Additional Manufacturer Narrative
The last calibration performed on 25-apr-2023 was ok and there were no alarms.Quality control recovery was within range.There was no indication of a reagent performance issue.Upon review of the alarm trace, no relevant alarms were observed.The investigation determined the service actions resolved the issue.Medwatch fields have been updated.

• Brand Name: TSH ELECSYS COBAS E 200 V2
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 16863228
• Report Number: 1823260-2023-01499
• Device Sequence Number: 6100092
• Product Code: JLW
• UDI-Device Identifier: 07613336157626
• UDI-Public: 07613336157626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: E411 RACK
• Device Catalogue Number: 08429324160
• Device Lot Number: 653309
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 05/08/2023; 06/07/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/24/2023; 06/23/2023
• 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