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

Catalog Number	08443432190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e801 analyzer is (b)(6).Medwatch field e1.Facility name - the full facility name was provided as (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with elecsys tsh on a cobas e 801 analytical unit.The tsh results were considered too high and the customer suspects the sample contains an interfering factor against a component of the tsh assay.The sample also had discrepant results for elecsys ft3 iii when compared to the ft3 value measured on a competitor system (siemens).This medwatch will apply to the tsh assy.Please refer to the medwatch with a1.Patient identifier (b)(6)for information related to the ft3 assay.Refer to the attachment for all patient data.The sample was tested at the customer site on (b)(6) 2023.The sample was repeated for tsh on the e801 analyzer after a x10 automatic dilution.Tsh was also re-measured on the e801 analyzer after being diluted x2 and treated with polyethylene glycol (peg).The sample was repeated for tsh and ft3 on a siemens analyzer.
Additional Manufacturer Narrative
Quality control data was acceptable.Since the elevated tsh and low ft3 results were confirmed with the siemens method, an interference with the elecsys assay can be excluded.The investigation did not identify a product issue.A reagent issue can be excluded.

• Brand Name: ELECSYS TSH
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17931397
• Report Number: 1823260-2023-03290
• Device Sequence Number: 12350495
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 09/30/2024
• Device Catalogue Number: 08443432190
• Device Lot Number: 72901301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: LANTUS INSULIN.; NOVORAPID INSULIN.
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: Asian