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

Model Number	FT3 G3
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Initial reporter - phone number:(b)(6).
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii and elecsys ft4 iii assay results for one patient tested on a cobas 8000 e 602 module.The serial number was requested but was not provided.It was requested but not provided if the initial results were reported outside the laboratory.Due to the tsh result not matching the clinical status of "graves," the customer performed repeat testing with the patient's sample on the cobas 8000 e 602 module, an abbott architect, and a beckman coulter analyzer.This medwatch is for ft3 assay.Refer to the medwatch with patient identifier (b)(6) for the ft4 assay.
Additional Manufacturer Narrative
H6: additional code 4315.

• Brand Name: ELECSYS FT3 III
• 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: 12720272
• Report Number: 1823260-2021-03163
• Device Sequence Number: 13003763
• Product Code: CDP
• UDI-Device Identifier: 04015630934171
• UDI-Public: 04015630934171
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K963127
• 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): 12/14/2021

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: 10/31/2021
• Device Model Number: FT3 G3
• Device Catalogue Number: 06437206160
• Device Lot Number: 507838
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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: LITHIUM
• Patient Age: 42 YR
• Patient Sex: Female