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

Model Number TSH

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable results for two samples from the same patient tested with the elecsys tsh ver.2 assay on a cobas 8000 e 801 module.The second sample also had a questionable tsh result when tested on a cobas 6000 e 601 module at a second site.The initial sample values were reported to a physician who complained the results did not match the patient's clinical picture.The first sample resulted in a tsh value of 58.900 miu/ml when tested on the e 801 analyzer.The second patient sample was tested three times on an abbott analyzer on (b)(6) 2021, resulting in tsh values of 10.7984 miu/l, 11.0647 miu/l, and 10.1620 miu/l.This sample resulted in a tsh value of 57.600 miu/ml when tested on the e 801 analyzer on (b)(6) 2021.This sample was repeated on an e 601 analyzer at the second site on (b)(6) 2021, resulting in a tsh value of 62.07 uiu/ml.The serial number of the e 801 analyzer is (b)(4).The serial number of the e 601 analyzer was requested, but not provided.

Manufacturer Narrative

Na.

Manufacturer Narrative

The correct unit of measure used for tsh on the e 801 analyzer is miu/l, not miu/ml.

Manufacturer Narrative

A sample from the patient was provided for investigation.Macro-tsh was detected in the sample, causing the observed high value.Per product labeling: "the presence of autoantibodies may induce high molecular weight complexes (macro-tsh) which may cause unexpectedly high values of tsh." the investigation could not identify a product problem.

• 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: 13203185
• MDR Text Key: 290527891
• Report Number: 1823260-2022-00071
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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,Followup,Followup
• Report Date: 02/23/2022

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 Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: 56833901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 01/31/2022; 01/31/2022
• Supplement Dates FDA Received: 01/31/2022; 02/23/2022
• 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
• Patient Age: 6 YR
• Patient Sex: Male