MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Catalog Number	ASKU
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer received questionable high elecsys ft4 ii assay and elecsys ft3 iii results for one patient sample from cobas 6000 e601 module serial number (b)(4).This medwatch is for ft3.Refer to the medwatch with patient identifier (b)(6) for the ft4 assay.The initial ft4 result was 30.08 pmol/l and initial ft3 result was 6.94 pmol/l.These results were reported outside of the laboratory and were questioned by the physician.The sample was repeated on an abbott analyzer.The ft4 result was 19.6 pmol/l and the ft3 result was 5.67 pmol/l.There was no allegation of an adverse event.
Additional Manufacturer Narrative
Sample from the patient was submitted for investigation.The customer's high ft4 and ft3 results were confirmed and no interfering factors were detected.The investigation was unable to find a definitive root cause.The differences in the results from different assay manufacturers, in this case abbott, can be due to differences in the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.

• Brand Name: ELECSYS FT3 III
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7736197
• Report Number: 1823260-2018-02518
• Device Sequence Number: 921258
• Product Code: CDP
• UDI-Device Identifier: 04015630934171
• UDI-Public: 04015630934171
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K963127
• 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): 08/06/2018

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: ASKU
• Device Lot Number: 277945
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1