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 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

Calibration and controls on the analyzers used for investigation were ok. 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 that they received discrepant results for two patient samples tested with the elecsys tsh assay on a cobas 8000 e 801 module and also a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer used for investigation. One of the two samples also had discrepant results for the elecsys ft4 iii assay. It was asked, but it is not known if any incorrect results were reported outside of the laboratory. This medwatch will apply to the tsh assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 iii assay. The samples were initially tested on the reporter's e 801 analyzer on (b)(6) 2019. The samples were repeated on a centaur analyzer. The samples were also provided for investigation, where they were tested on the second e 801 analyzer on (b)(6) 2019 and the e 602 and e411 analyzers on (b)(6) 2019. The serial number of the e 801 analyzer used at the reporter's site was (b)(4). The serial number of the e 602 analyzer used for investigation is (b)(4). Tsh reagent lot number 394674, with an expiration date of 31-oct-2019 was used on this analyzer. The serial number of the e411 analyzer used for investigation is (b)(4). Tsh reagent lot number 394674, with an expiration date of 31-oct-2019 was used on this analyzer. The serial number of the e 801 analyzer used for investigation is (b)(6). Tsh reagent lot number 386646, with an expiration date of 31-may-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: 8912136
• MDR Text Key: 175720713
• Report Number: 1823260-2019-03051
• 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: 08/20/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TSH
• Device Catalogue Number: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2019
• 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