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 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous high results for 1 patient sample tested for ft3 -free triiodothyronine (ft3 iii) and free thyroxine (ft4 ii).The customer thinks the values do not fit the clinical picture for the patient.Comparison testing was performed between an e601 analyzer and an abbott instrument.The erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.The initial ft3 iii result was 10.4 ng/l.The initial ft4 ii result was 5.55 ng/dl.Both results were reported outside of the laboratory.On (b)(6) 2015, the sample was repeated and the ft3 iii result was 8.71 ng/l.The repeat ft4 ii result was 2.55 ng/dl.On an unknown date, the sample was repeated on an abbott instrument and the ft3 result was 4.39 pmol/l.The repeat ft4 result was 10.43 pmol/l.No adverse event occurred.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

The sample was submitted for investigation.Investigation confirmed the presence of a streptavidin interfering factor.This specific interference is addressed 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: 5225545
• MDR Text Key: 31334241
• Report Number: 1823260-2015-04552
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/02/2015

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: 10/30/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• 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: 055 YR