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

Model Number TSH

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.From the information provided, a general reagent issue could be excluded.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.

Event Description

There was an allegation of questionable thyroid results for one patient from cobas e 801 module serial number (b)(4).The results were reported outside of the laboratory and were questioned by the physician because the result for tsh was elevated even though the patient's thyroid is not currently underactive.The medwatch with patient identifier (b)(6) is for the tsh assay and the medwatch with patent identifier (b)(6) is for the ft3 assay.

• Brand Name: ELECSYS TSH
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13731650
• MDR Text Key: 293084170
• Report Number: 1823260-2022-00659
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "EPILEPSY MEDICATION"; DEPAKENE (SODIUM VALPROATE); THYRADIN (LEVOTHYROXINE SODIUM HYDRATE); VIMPAT (LACOSAMIDE)