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

Model Number TSH

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for a total of 9 patient samples tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module. 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 ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay. The samples were initially tested on this customer's e801 analyzer on (b)(6) 2019. The samples were repeated on a centaur analyzer. The samples were provided for investigation where they were tested on a cobas 8000 e 602 module on (b)(6) 2019. For investigation, the samples were also tested on a second e801 analyzer and a cobas e 411 immunoassay analyzer on (b)(6) 2019. No adverse events were alleged to have occurred with the patients. The serial number of the e602 analyzer used for investigation is (b)(4). Tsh reagent lot number 394674, with an expiration date of 30-jun-2019 was used on this analyzer. The serial number of the e801 analyzer used for investigation is (b)(4). Tsh reagent lot number 365417, with an expiration date of 28-feb-2020 was used on this analyzer. The serial number of the e411 analyzer used for investigation is (b)(4). Tsh reagent lot number 373386, with an expiration date of 30-jun-2019 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: 8772234
• MDR Text Key: 150553701
• Report Number: 1823260-2019-02482
• 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,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/09/2019
• 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: 06/18/2019
• 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