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

Catalog Number	08443432190
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e801 analyzer is (b)(6).A sample from the patient was requested for investigation, but there was none available.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys tsh on a cobas e 801 analytical unit in comparison to results obtained on a competitor platform.The sample was tested twice on the e801 analyzer, resulting in tsh values of 0.011 uiu/ml and 0.011 uiu/ml.The sample was also tested twice on the competitor platform, resulting in tsh values of 1.012 uiu/ml and 1.012 uiu/ml.The results measured on the competitor platform were believed to the correct values.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The competitor system was manufactured by siemens.

• 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: 18702716
• Report Number: 1823260-2024-00433
• Device Sequence Number: 17946224
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• 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,Followup
• Report Date (Section B): 03/20/2024

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: 741899
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 01/30/2024; 03/18/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 02/22/2024; 03/20/2024
• 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
• Patient Sex: Unknown