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	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned high results for 1 patient tested for elecsys tsh (tsh) on a cobas e 801 module.The patient was tested on (b)(6) 2023 and (b)(6) 2023 with tsh results greater than 100 uiu/ml on the e801 module.These results were from separate samples.The high results did not correspond to the patient¿s clinical condition.The sample from (b)(6) 2023 was tested by the siemens method and the tsh result was within the reference range (approximately 5 uiu/ml).
Additional Manufacturer Narrative
Section e3: occupation is roche account manager.The e801 module serial number was (b)(6).The samples were requested for investigation.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Sample material was received for investigation.Upon investigation of the sample with size exclusion chromatography (sec), macro-tsh was detected in the sample which caused the high tsh results.Product labeling states: "the presence of autoantibodies may induce high molecular weight complexes (macro-tsh) which may cause unexpectedly high values of tsh.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: 17693602
• Report Number: 1823260-2023-02894
• Device Sequence Number: 15047507
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 08443432190
• Device Lot Number: 72901301
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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 Age: 6 YR
• Patient Sex: Male