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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's calibration and qc results were ok.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys t3 results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient's elecsys t3 result was not reported outside the laboratory.The customer performed repeat testing with the patient's sample on the cobas 8000 e 801 module as well on a siemens advia centaur analyzer.The date of testing with the siemens advia centaur analyzer was requested but not provided.On (b)(6) 2021, the patient's elecsys t3 result was 651 ng/dl with a data flag.The patient's t3 result on the siemens advia centaur analyzer was 87 ng/dl.On (b)(6) 2021, the patient's repeat elecsys t3 result was 651 ng/dl with a data flag.The customer determined the result of 87 ng/dl was correct.
Additional Manufacturer Narrative
The patient's sample was requested for an investigation, but the sample was not available.From the provided information, a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS T3
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12589188
• Report Number: 1823260-2021-02929
• Device Sequence Number: 14473225
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 06/30/2022
• Device Catalogue Number: 07027869190
• Device Lot Number: 53024701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARADOIS; CHLORAHYDRATIDE; PLENANCE; TORVAL CR; ARADOIS; CHLORAHYDRATIDE; PLENANCE; TORVAL CR
• Patient Age: 50 YR
• Patient Sex: Female