MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	08429324160
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tsh results from the cobas 8000 - cobas e 602 module.The initial result was 0.2 miu/ml and was reported outside of the laboratory.The physician did not agree with the result.A week later, the repeat result from the same sample was 1.87 miu/ml.Neither result was believed to be correct.
Additional Manufacturer Narrative
The cobas 8000 - cobas e 602 module serial number was (b)(6).The field service engineer determined there was a calibration issue.The customer replaced the reagent pack and performed calibration and qc that were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TSH ELECSYS COBAS E 200 V2
• 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 46250-0457
• MDR Report Key: 18614448
• Report Number: 1823260-2024-00282
• Device Sequence Number: 14045640
• Product Code: JLW
• UDI-Device Identifier: 07613336157626
• UDI-Public: 07613336157626
• 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
• Report Date (Section B): 02/12/2024
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2024
• Device Catalogue Number: 08429324160
• Device Lot Number: 70052401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/12/2024
• 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: ACETAMINOPHEN; ALENDRONATE; ASPRIN; BACLOPHEN; CALCIUM CARBONATE; CENTRO; DIAZEPAM; DOCUSATE; ESCITALOPRAM; GABAPENTIN; IMODIPIN; LIDOCAINE; MAGNESIUM OXIDE; POLYEHTELYNE GLYCO; TERBINAFIENE; TRAZEDONE; VITAMIN D3
• Patient Age: 83 YR
• Patient Sex: Male