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 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

The sample from the patient was submitted for investigation where the customer's high tsh value was confirmed.Upon further analysis, no interfering factors for the tsh assay were detected.Using size exclusion chromatography, a macrotsh was not present in the sample.Differences between the tsh results generated with the different analyzers are caused by differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.From the information provided and the analysis of the sample, a general reagent issue could be excluded.

Event Description

The initial reporter received questionable elecsys tsh assay results on a cobas e 801 module.On (b)(6) 2022, the initial tsh result was 22.4 miu/l.The result was reported outside of the laboratory.The physician questioned the result as it did not fit the patient's clinical picture.On (b)(6) 2022, the sample was repeated on an abbott architect analyzer.The tsh result was 13.7802 uui/ml.The sample was also repeated on the e801 with a peg dilution.The tsh result was 7.86 miu/l.The peg result does not match the clinical results either; for this reason, the physician suspects a possible interference (e.G.A macro-tsh).It is not known which result was deemed correct.The reagent expiration date was requested but not provided.This medwatch covers tsh.Refer to the medwatch with patient identifier (b)(6) for information on the ft4 iii results.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15184617
• MDR Text Key: 302927560
• Report Number: 1823260-2022-02358
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• 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: 622589
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• 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: AMIODARONE; EUTIROX 75; FUROSEMIDE
• Patient Age: 52 YR
• Patient Sex: Female