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 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received an erroneous result for one patient sample tested for free thyroxine (ft4).The sample initially resulted as 33 pmol/l when tested on the e602 analyzer.The result was said to not fit the patient's clinical picture.It was asked, but it is not known if the erroneous result was reported outside of the laboratory.The sample was repeated on an abbott architect analyzer, where it resulted as 16 pmol/l.The patient was not adversely affected.The e602 analyzer serial number was (b)(4).

Manufacturer Narrative

The ft4 result from the e602 analyzer was not reported outside of the laboratory.

Manufacturer Narrative

A sample from the patient was provided for investigation.The ft4 value that the customer obtained could not be reproduced.The result from the investigated sample was, however, above the normal reference range like the value that the customer obtained.Investigation of the sample havs determined that the sample contains an interferent to the streptavidin present in the ft4 reagent.This limitation is covered in product labeling.The incorrect result was not reported to the clinician.

• 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: 5249905
• MDR Text Key: 32108232
• Report Number: 1823260-2015-04627
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/16/2015

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: 186318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/08/2015; 12/16/2015
• 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