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

Catalog Number 04388780190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 ii assay, and the elecsys anti-tshr immunoassay on a cobas e 411 immunoassay analyzer.The ft3 and ft4 results from the e411 analyzer were higher than results obtained on an abbott architect analyzer.The physician also doubts the non-reactive anti-tshr result from the e411 analyzer.This medwatch will apply to the anti-tshr 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 patient sample was initially tested on the customer's e411 analyzer on (b)(6) 2018.The sample was repeated for ft3 and ft4 on an abbott architect analyzer.The sample was repeated for anti-tshr using the yamasa method.The sample was also provided for investigation where it was tested on an e 801 analyzer.No adverse events were alleged to have occurred with the patient.The serial number of the customer's e411 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Anti-tshr reagent lot number 359355, with an expiration date of november 2019 was used on this analyzer.

Manufacturer Narrative

From the provided information, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8332916
• MDR Text Key: 136004836
• Report Number: 1823260-2019-00577
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04388780190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THIAMAZOLE
• Patient Age: 56 YR