MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T3; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Catalog Number	07027869190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).In medwatch field the patient's age was provided as 10 to 20 years old.
Event or Problem Description
The customer complained of questionable elecsys t3 results for 1 patient sample on a cobas 6000 e 801 module and a cobas 6000 e 601 module.Of the data provided, there were discrepant t3 and elecsys ft4 ii assay results.The e 801 serial number is (b)(4) the e 601 serial number is (b)(4).This medwatch will cover the t3 data.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results.The initial t3 result was 422 ng/dl on the e 801.The physician requested a repeat for the t3 result.The repeat t3 result was 423 ng/dl on the e 801.The sample was repeated on an e 601 and the t3 result was 166.6 ng/dl.The initial ft4 ii result was 0.915 ng/dl on the e 801.After the physician requested the repeat of the sample the ft4 result was 0.919 ng/dl on the e801.The sample was repeated on an e 601 and the ft4 ii result was 1.43 ng/dl.No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.
Additional Manufacturer Narrative
The investigation identified an interfering factor in the patient's sample that affects the reagent.This interference is covered in product labeling.Calibration and internal qc results within expectations.For diagnostic purposes, the results should always be assessed in conjunction with the patient´s medical history, clinical examinations and other findings.
Additional Manufacturer Narrative
The customer provided a sample for investigation.Investigation of the sample confirmed the sample contained an immunoglobulin that reacts with the reagent which affects the sample results.The investigation is ongoing.

• Brand Name: ELECSYS T3
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7834066
• Report Number: 1823260-2018-02930
• Device Sequence Number: 19224271
• Product Code: CDP
• UDI-Device Identifier: 04015630939794
• UDI-Public: 04015630939794
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K962508
• 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,Followup
• Report Date (Section B): 11/30/2018

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: 07027869190
• Device Lot Number: 291614
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 08/10/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/18/2018; 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1