MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Catalog Number 09043284190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 07/20/2023

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys ft4 iv assay result from one patient sample tested on the cobas e 801 module.The initial result was reported to the physician who deemed the result implausible, prompting the rerun of the patient sample.The patient sample was rerun on the module and two other modules (module 1 and module 2).The initial result from the module, with the patient sample in a hitachi cup on a tube, was 0.129 ng/dl.The first repeat result from the module, with the patient sample in a hitachi cup on a tube was 5.21 ng/dl.The second repeat result from module 1 using a different reagent lot and with the patient sample in a microcup was a data flag with no numeric result.The third repeat result from module 1 using a different reagent lot and with the patient sample in a microcup was 5.67 ng/dl.The fourth repeat result from module 2, with the patient sample in a micro cup was 5.88 ng/dl.The third and fourth repeat results confirmed the first repeat result.

Manufacturer Narrative

The serial number of the customer's cobas e 801 module is (b)(6).Based on the information provided, a general reagent problem could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 IV
• Type of Device: FREE THYROXINE
• 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: 17559780
• MDR Text Key: 321752307
• Report Number: 1823260-2023-02661
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: K220456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09043284190
• Device Lot Number: 72497402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female