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

Catalog Number	08443432190
Medical Device Problem Codes	High Test Results (2457); Chemical Problem (2893); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 module a serial number was (b)(6).The e801 module b serial number was (b)(6).
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys tsh (tsh) on two cobas 8000 e 801 modules compared to the siemens method.The initial result from e801 module a was 19.90 uiu/ml.The repeat result from e801 module b was 23.50 uiu/ml.The sample was sent to another hospital using the siemens vista method and the result was <0.005 uiu/ml.The customer suspects an interference.
Additional Manufacturer Narrative
Section b3, date of event was updated.Section b7 was updated.Section d10 was updated.The sample was requested for investigation.
Additional Manufacturer Narrative
The sample was received for investigation.The customer's high tsh results were reproduced.Further investigation of the sample confirmed an interference against the ruthenium component of the reagent.This interference caused the high tsh results.Product labeling states: "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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." 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: 17847693
• Report Number: 1823260-2023-03137
• Device Sequence Number: 7095182
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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): 02/08/2024

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: 11/30/2024
• Device Catalogue Number: 08443432190
• Device Lot Number: 733296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 02/06/2024
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 12/11/2023; 02/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEVOTHYROXINE; LIOTHYRONINE; MULTIVITAMIN
• Patient Sex: Unknown