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	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s e801 module serial number was (b)(6).The e801 module serial number used at the investigation site was (b)(6).The e411 analyzer serial number used at the investigation site was (b)(6).The tsh reagent lot number used with the e411 analyzer was 660341 with an expiration date of 31-aug-2023.The tsh reagent lot number used with the e801 module at the investigation site was 706398 with an expiration date of 30-jun-2024.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned the results for 4 patient samples tested for elecsys tsh (tsh), elecsys ft4 iv (ft4 iv) and elecsys ft3 iii (ft3 iii).The results were reported outside of the laboratory where additional testing was requested.The samples were submitted for investigation where discrepant results were identified for tsh, ft4 and ft3 iii between the customer¿s e801 module, an e801 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site and the abbott architect method.This medwatch will cover tsh.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft4 results and medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.Refer to the attached for the patient results.
Additional Manufacturer Narrative
Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.From the information provided, a general reagent issue can be excluded.The investigation did not identify a product problem.

• 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: 17567063
• Report Number: 1823260-2023-02679
• Device Sequence Number: 20499583
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 09/07/2023

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 Catalogue Number: 08443432190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/07/2023
• 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