MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number	07027885190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer stated that they received erroneous results for two patient samples tested with elecsys t3 on a cobas 8000 e 801 module.The second sample also had an erroneous result for the elecsys t4 assay when tested on the same e 801 analyzer.No erroneous results were reported outside of the laboratory.This medwatch will apply to the t4 assay.Patient identifier (b)(6) for information related to the t3 assay.Refer to the attachment for all patient data.The erroneous results are highlighted in red.The correct results which were reported outside of the laboratory are highlighted in yellow.All erroneous results were generated on the e 801 analyzer.The samples were repeated on 4 different roche diagnostics elecsys e170 modular analytics immunoassay analyzers.No adverse events were alleged to have occurred with the patients.The serial number of the e 801 analyzer is (b)(4).
Additional Manufacturer Narrative
The customer provided one sample for investigation.An interfering factor against a component of the reagent was detected.The package insert states the following disclaimer: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.As the other sample was not provided for investigation, the cause of that event could not be determined.

• Brand Name: ELECSYS T4 ASSAY
• Common Device Name: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8023317
• Report Number: 1823260-2018-03954
• Device Sequence Number: 1353135
• Product Code: CDX
• UDI-Device Identifier: 04015630939800
• UDI-Public: 4015630939800
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K961490
• 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): 11/13/2018

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 Expiration Date: 03/31/2019
• Device Catalogue Number: 07027885190
• Device Lot Number: 287093
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR