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

Catalog Number	07027362190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 5 patient samples tested for elecsys ft3 iii (ft3 iii) on a cobas e 801 analytical unit.Patient 1 initial result was 40.3 pmol/l.The repeat result was 4.81 pmol/l.Patient 2 initial result was 10.8 pmol/l.The repeat result was 4.10 pmol/l.Patient 3 initial result was 9.88 pmol/l.The repeat result was 4.99 pmol/l.Patient 4 initial result was 7.27 pmol/l.The repeat result was 5.85 pmol/l.Patient 5 initial result was 7.70 pmol/l.The repeat result was 5.41 pmol/l.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The customer checked how the reagent pack was being stored and noted that the ft3 reagent pack was lying down and not upright.The 5 patient samples were repeated later the same day and the ft3 iii results were reproducible.The customer suspects bubbles in the reagent at the time of the event earlier in the day.The investigation is ongoing.
Additional Manufacturer Narrative
Qc was acceptable, however, it was not provided which reagent pack was used.No issues were identified during a review of the alarm trace.Precision testing from 14-jan-2024 was acceptable.The investigation determined the event was consistent with either foam on the reagent surface or a sample clot in the measuring cell.The specific cause of the event could not be determined.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18659208
• Report Number: 1823260-2024-00352
• Device Sequence Number: 7129245
• Product Code: CDP
• UDI-Device Identifier: 04015630939718
• UDI-Public: 04015630939718
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K963127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/04/2024

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: 10/31/2024
• Device Catalogue Number: 07027362190
• Device Lot Number: 740474
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/04/2024
• 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
• Patient Sex: Unknown