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 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received erroneous results for two samples from the same patient tested for thyrotropin (tsh), free triiodothyronine (ft3), and free thyroxine (ft4) on an e601 analyzer.The values for ft3 and ft4 were said to be implausibly high and did not compare to results obtained with other manufacturer analyzers.The ft3 and ft4 values also did not fit the clinical picture of the patient.This medwatch will cover ft4.(b)(4).The first sample resulted as 0.59 miu/l for tsh, 12.55 pmol/l for ft3, and 51.0 pmol/l for ft4 on (b)(6) 2015.A value of 11.09 pmol/l was also provided for ft3, but it is not known if this value may have been provided in error.A clarification has been requested.A second sample, collected and tested on (b)(6) 2015, resulted as 1.33 miu/l for tsh, 11.09 pmol/l for ft3, and 45.8 pmol/l for ft4.The 11.09 pmol/l ft3 value and the 45.8 pmol/l ft4 value were reported outside of the laboratory.This sample was repeated on (b)(6) 2015, resulting as 1.31 miu/l for tsh, 11.18 pmol/l for ft3, and 49.80 pmol/l for ft4.The sample was repeated a second time on (b)(6) 2015, resulting as 1.32 miu/l for tsh, 11.21 pmol/l for ft3, and 47.12 pmol/l for ft4.One of the two samples was sent to three other laboratories for testing on a beckman analyzer, a siemens analyzer, and an abbott analyzer.It was not known which sample was provided for repeat testing on these analyzers.The units of measure used on the beckman and siemens analyzers also are not known.Clarifications have been requested.One of the two samples resulted as 2.25 for tsh, 6.94 for ft3, and 13.7 for ft4 when tested on a beckman analyzer at a second laboratory.One of the two samples resulted as 2.30 for tsh, 5.00 for ft3, and 14.5 for ft4 when tested on a siemens analyzer at a third laboratory.One of the two samples resulted as 2.08 miu/l for tsh, 5.0 pmol/l for ft3, and 14.1 pmol/l for ft4 when tested on an abbott analyzer at a fourth laboratory.The patient was not adversely affected.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

For the first sample, it has been clarified that the ft3 value of 11.09 pmol/l was provided in error and should be disregarded.The units of measure used on both the beckman and siemens analyzers are mu/l for tsh, pmol/l for ft3, and pmol/l for ft4.The second sample, collected on (b)(6) 2015, was used to obtain the values measured on the beckman, siemens, and abbott analyzers.The second sample, collected on (b)(6) 2015, was provided for investigation.Investigations of the sample have concluded that there is an interfering factor present in the sample which interferes with the streptavidin present in the ft3 and ft4 reagents.This interference is covered in product labeling.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5144166
• MDR Text Key: 28454092
• Report Number: 1823260-2015-04316
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 10/21/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: 186893
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 051 YR