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 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer questioned results for 2 samples from 1 patient tested for elecsys tsh assay (tsh), elecsys t3 (t3), elecsys ft4 ii assay (ft4 ii), elecsys anti-tpo (anti-tpo), elecsys anti-tg (anti-tg) and elecsys anti-tshr immunoassay on a cobas 6000 e 601 module compared to the centaur and ria methods.Based on the data provided, the tsh, t3, ft4 ii, anti-tpo and anti-tshr results were discrepant.This medwatch will cover anti-tshr.Refer to medwatch with patient identifier (b)(6) for information on the tsh results, medwatch with patient identifier (b)(6) for information on the t3 results, medwatch with patient identifier (b)(6) for information on the ft4 ii results and medwatch with patient identifier (b)(6) for information on the anti-tpo results.It is not known if the erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The customer suspects an interference affecting the results.The e601 module serial number was (b)(4).The samples were requested for investigation but could not be provided.Based on the calibration and qc data, a general reagent issue can be excluded.Since the sample could not be provided, the investigation could not be completed.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.

Manufacturer Narrative

A new sample was obtained on (b)(6) 2019 and additional tests were performed.The customer also repeated a previous patient sample on (b)(6) 2019.The customer suspects an interference.Refer to attached data for the results.The new sample from (b)(6) 2019 was submitted for investigation.The investigation is ongoing.

• 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: 8151776
• MDR Text Key: 130488003
• Report Number: 1823260-2018-04782
• 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,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• 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: 335843
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR