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

Catalog Number	07026951190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned thyroid results for 1 patient sample.No results from the customer site were provided, but the sample was provided for investigation.The patient sample was tested for elecsys ft4 ii assay (ft4 ii), elecsys tsh assay (tsh), elecsys ft4 iii (ft4 iii), elecsys ft3 iii (ft3 iii) and elecsys anti-tshr immunoassay on a cobas e 801 module and a cobas e 411 immunoassay analyzer used at the investigation site.Based on the results generated during the testing at the investigation site, the results for ft3 iii and anti-tshr were discrepant.Based on the results generated for ft4 iii, the customer suspects an interference.Refer to attached data for the patient results.This medwatch will cover anti-tshr.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the ft4 iii results.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The customer's instrument type and serial number were not provided.The e801 module serial number used at the investigation site was (b)(4).The e411 module serial number used at the investigation site was (b)(4).The anti-tshr reagent lot number used with the e801 module at the investigation site was 322386 with an expiration date of mar-2019.The anti-tshr reagent lot number used with the e411 analyzer was 307888 with an expiration date of apr-2019.
Additional Manufacturer Narrative
Upon investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.

• Brand Name: ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR
• Common Device Name: ANTI-TSHR IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7772891
• Report Number: 1823260-2018-02685
• Device Sequence Number: 1392441
• Product Code: JZO
• UDI-Device Identifier: 04015630939954
• UDI-Public: 04015630939954
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07026951190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1