MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR; ANTI-TSHR IMMUNOASSAY

Model Number ANTI-TSHR

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 iii assay, roche diagnostics cobas elecsys anti-tpo, and the elecsys anti-tshr immunoassay on a cobas 8000 e 801 module.The sample also had discrepant values when tested on a cobas e 411 immunoassay analyzer and a second e 801 analyzer used for investigation.Incorrect results from the sample were reported outside of the laboratory to a physician.This medwatch will apply to the anti-tshr assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay, 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 anti-tpo assay.The sample was initially tested at the customer site on an e 801 analyzer.Repeat measurements for anti-tg and anti-tpo were performed on an architect analyzer.The anti-tshr measurement was repeated using the yamasa method.The sample was also provided for investigation, where it was tested using a second e 801 analyzer and an e411 analyzer.The serial number of the reporter's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Anti-tshr reagent lot number 408206, with an expiration date of june 2020 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Anti-tshr reagent lot number 390507, with an expiration date of june 2020 was used on this analyzer.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.Differences in values generated with the different types of analyzers can be caused by differences in the setups of the assays, differences in the antibodies used, and differences of the standardization materials and procedures used.

• Brand Name: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Type of Device: ANTI-TSHR IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8907385
• MDR Text Key: 175715867
• Report Number: 1823260-2019-03037
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K080092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

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 Model Number: ANTI-TSHR
• Device Catalogue Number: 07026951190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR