MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT4, FREE THYROXINE; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous high results for one patient sample tested with elecsys ft3 iii and the elecsys ft4 ii assay on a cobas 6000 e 601 module.The erroneous ft3 and ft4 results were reported outside of the laboratory.The physician suspected that the sample contained an interferent which affects the ft3 and ft4 assays.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.The sample resulted with a ft3 value of 26.6 pg/ml (reference range = 2.0 - 4.4 pg/ml) and ft4 value of 2.36 ng/dl (reference range = 0.93 - 1.70 ng/dl).No adverse events were alleged to have occurred with the patient.The e 601 analyzer serial number is (b)(4).

Manufacturer Narrative

The complained patient sample was tested on an abbott architect analyzer, resulting with the following values: tsh = 0.23 uiu/ml (reference range = 0.35 - 4.94 uiu/ml), ft4 = 1.64 ng/dl (reference range = 0.70- 1.48 ng/dl), and ft3 = > 20.00 pg/ml (reference range = 1.88-3.18 pg/ml).The ft3 and ft4 values measured with both roche and abbott analyzers were all above each assay's respective reference ranges.The differences in ft3 and ft4 values measured with the roche and abbott assays most likely relates to the overall setups of the assays, the antibodies used, differences in reference materials, and differences in the standardization methodology used.A general reagent issue can most likely be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7938969
• MDR Text Key: 123959387
• Report Number: 1823260-2018-03441
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1