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

Model Number	TSH
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Summary of investigation results: the investigation is ongoing.2.Summary of follow up/corrective actions taken: the investigation is ongoing.3.Device returned to manufacturer? no 4.Device labeled "for single use?"? no 5.Device reprocessed and reused? no.
Event or Problem Description
1.Describe the event: there was an allegation of questionable high elecsys tsh results for 2 patient samples.2.Patient age range: 1 patient: 86 years, other: asku 3.Patient weight range: asku 4.Patient sex breakdown: 1 f, 1 asku 5.Patient race breakdown: asku 6.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
Summary of investigation results: no interfering factors were identified.The investigation did not identify a product problem.The cause of the event could not be determined.Summary of follow up/corrective actions taken: one patient sample was submitted for investigation.Device returned to manufacturer? no devices were returned.Device labeled "for single use?"? this device is not labeled for single use.Device reprocessed and reused? this device is not reprocessed or reused.

• 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 46250-0457 ; 3175216208
• MDR Report Key: 19203013
• Report Number: 1823260-2024-01306
• Device Sequence Number: 8142245
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: 76836101
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/02/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown