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 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date was provided as "2017 jan." this event occurred in (b)(6).(b)(4).

Event Description

The customer received questionable thyroid results for one patient who had been transferred from another clinic.The patient had been tested at that site on an unknown roche analyzer and the elecsys ft4 assay result was 1.78 ng/dl.On (b)(6) 2016, a new sample from the patient was drawn and was tested by the customer on (b)(6) 2016 on an abbott architect (clia) and the ft4 result was 1.29 ng/dl.The customer suspected that a "non-specific reaction" had occurred when testing ft4.The sample from (b)(6) /2016 was submitted for investigation and was tested on (b)(6) 2016 on modular-pe analyzer serial number (b)(6) and the ft4 result was 1.86 ng/dl.Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown.The patient was not adversely affected.Refer to the medwatches with patient identifiers (b)(6) for the other assays involved in the complaint.

Manufacturer Narrative

A specific root cause could not be determined.Sample from the patient was submitted for investigation.The result was confirmed and no interfering factors to the assay were detected.Based on these results, a product problem could not be found.The differences in the results between methods could be due to the overall setups of the assays, the antibodies used, and differences in the reference materials/methods and the standardization methodology used.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 5986339
• MDR Text Key: 55886777
• Report Number: 1823260-2016-01484
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• 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: 125827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• 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: 27 YR