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 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

The patient sample was provided for investigation.During the investigation, ft3 and ft4 measurements from the sample were above the respective assay ranges.The presence of an interfering factor against streptavidin used in the ft3 and ft4 reagents could be excluded.The investigation is currently ongoing.(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, and the elecsys anti-tshr immunoassay on a cobas 8000 e 801 module.The values did not match when compared to competitor methods.The values from the e 801 analyzer were reported outside of the laboratory and the competitor method results were believed to be correct.Until 2012, the patient had ft3, ft4, and tsh values which were within the reference range of the assays.Since (b)(6) 2013, the patient's ft3, ft4, and anti-tshr values have been increasing while tsh values are still normal.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.When tested on the e 801 analyzer, the sample resulted with a ft3 value of 7.63 pmol/l and when repeated on a siemens centaur analyzer, the value was 3.6 ng/l.When tested on the e 801 analyzer, the sample resulted with a ft4 value of 42.7 pmol/l and when repeated on a siemens centaur analyzer, the value was 1.4 ng/dl.When tested on the e 801 analyzer, the sample resulted with an anti-tshr value of 11.9 iu/l and when repeated on a thermo fisher cryptor analyzer, the value was normal.No adverse events were alleged to have occurred with the patient.The serial number of the e 801 analyzer is (b)(4).

Manufacturer Narrative

An interfering factor to sulfo ru-label was identified in the investigated sample.The interference is documented in product labeling.The investigation did not identify a product problem.

• 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: 8649782
• MDR Text Key: 146385796
• Report Number: 1823260-2019-01987
• 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: 07/03/2019

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 Expiration Date: 11/30/2019
• Device Model Number: ANTI-TSHR
• Device Catalogue Number: 07026951190
• Device Lot Number: 35935501
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR