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	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 module is (b)(6).The competitor method is siemens.The patient sample has been requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with elecsys tsh on a cobas e 801 module.The customer stated that the result obtained with the roche method does not match the patient's clinical picture of hyperthyroidism.Measurements of the same patient obtained with a competitor method match the patient's clinical picture.The customer stated that discrepancies between roche and the competitor have occurred before with other samples from the same patient starting in 2020.No specific results were provided related to this allegation.The sample in question resulted in a tsh value of 2.29 uui/ml (reference range = 0.27 - 4.20 uui/ml) when tested with the roche method on 20-oct-2023.The sample was repeated with the competitor method on 20-oct-2023, resulting in a tsh value of 0.007 uui/ml.
Additional Manufacturer Narrative
The patient sample was provided for investigation and the results obtained by the customer could be reproduced.Further investigations of the sample determined that it contains an interfering factor against the ruthenium label of the tsh 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." the investigation did not identify a product issue.

• 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: 18144452
• Report Number: 1823260-2023-03619
• Device Sequence Number: 15174533
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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): 12/13/2023

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: 73329600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/13/2023
• 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: ACTRAPID (10/12-10/12-0-0); HUMALOG KWIKPEN (0-0-14/16-0-0); LANTUS (0-0-0-17)
• Patient Age: 39 YR
• Patient Sex: Female