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

Catalog Number	07027869190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer received questionable elecsys t3 result for three patient samples from cobas 8000 e 801 module serial number (b)(4).Of the data provided, only the results for two of the samples were discrepant.Patient 1 initial results were 456 and 466 ng/dl.The repeat results from another cobas 8000 e 801 module were 390 and 387 ng/dl.The repeat result from a roche diagnostics elecsys e170 modular analytics immunoassay analyzer was 168 ng/dl.The repeat result from a cobas 8000 e 602 module was 169 ng/dl.On (b)(6) 2018, patient 2 initial result was 425 ng/dl.The sample was repeated on a cobas 6000 e 601 module and the results were 256.6 ng/dl and 264.4 ng/dl.This result was considered correct and released to the patient.The sample was repeated on the 8000 e 801 module and the result was 382 ng/dl.This patient was a (b)(6) female.No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.
Additional Manufacturer Narrative
The customer provided sample from patient 1 for investigation.The investigation found an interfering factor against the streptavidin component of the reagent.The package insert states 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.

• 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: 8008927
• Report Number: 1823260-2018-03865
• Device Sequence Number: 18869123
• Product Code: CDP
• UDI-Device Identifier: 04015630939794
• UDI-Public: 04015630939794
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 11/21/2018

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: 10/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR