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
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.
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 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