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

Model Number TSH

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.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 differences in the standardization methodology used.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay ver.2 on the customer's cobas 8000 e 801 module and with the elecsys tsh assay on a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.The values generated at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the elecsys tsh assay ver.2.Please refer to the medwatch with patient identifier (b)(6) for information related to the elecsys tsh assay.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on 28-jul-2020.The sample was repeated on a siemens centaur analyzer.The sample was also provided for investigation, where it was tested on a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer on 30-jul-2020.The e 801 analyzer used at the customer site is serial number (b)(4).The e 801 analyzer used for investigation is serial number (b)(4).Elecsys tsh assay reagent lot number 440688, with an expiration date of 31-mar-2021 was used on this analyzer.The e 602 analyzer used for investigation is serial number (b)(4).Elecsys tsh assay reagent lot number 444797, with an expiration date of 31-aug-2020 was used on this analyzer.The e 411 analyzer used for investigation is serial number (b)(4).Elecsys tsh assay reagent lot number 455423, with an expiration date of 31-oct-2020 was used on this analyzer.

• Brand Name: ELECSYS TSH ASSAY
• 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: 10449865
• MDR Text Key: 204433208
• Report Number: 1823260-2020-02100
• Device Sequence Number: 1
• Product Code: JLW
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 08/04/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1