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 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.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).(b)(4).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay on a cobas 8000 e 801 module.The sample also had discrepant tsh values when tested on a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer used for investigation.The values measured by the customer were reported outside of the laboratory to a physician.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on a siemens centaur analyzer.The sample was also provided for investigation, where it was tested on an e 601 and e 411 analyzer on (b)(6) 2020 and a second e 801 analyzer on (b)(6) 2020.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 602 analyzer used for investigation is (b)(4).Tsh reagent lot number 429091, with an expiration date of 30-apr-2020 was used on this analyzer.The serial number of the e 411 analyzer used for investigation is (b)(4).Tsh reagent lot number 429901, with an expiration date of 30-apr-2020 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(4) tsh reagent lot number 416233, 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: 9695476
• MDR Text Key: 219784091
• Report Number: 1823260-2020-00389
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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: 07028091190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• 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