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

Catalog Number 09005803190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys ft3 iii results for 2 patient samples on a cobas 6000 e 601 module.The customer questioned the high initial and repeat results as they did not match the patients' clinical histories and was prompted to change the reagent pack and repeat the samples again.For patient 1, the initial ft3 result was 12.8 pmol/l.The sample was auto-repeated and the result was 12.9 pmol/l.The sample was repeated again with a different reagent pack and the result was estimated to be 2-3 pmol/l.For patient 2, the initial ft3 result was 10.8 pmol/l.The sample was auto-repeated and the result was 11.95 pmol/l.The sample was repeated again with a different reagent pack and the result was estimated to be 2-3 pmol/l.No questionable results from patient 2 were reported outside of the laboratory.The estimated results of 2-3 pmol/l were deemed correct.

Manufacturer Narrative

The qc recovery data provided was acceptable.The alarm trace showed sample short and abnormal probe sucking alarms.The customer replacing the reagent pack resolved the issue.No further issues were reported.

• Brand Name: ELECSYS FT3 III
• Type of Device: 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: 18607939
• MDR Text Key: 334658724
• Report Number: 1823260-2024-00262
• Device Sequence Number: 1
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09005803190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1