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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable free thyroxine (ft4) results for one patient sample from cobas e601 serial number (b)(4).The initial result was 4.60 ng/dl.The repeat result was 4.83 ng/dl.On (b)(6) 2015, the sample was repeated again and the result was 4.94 ng/dl.An aliquot of the same sample was sent to a second laboratory and tested on an abbott architect.The result was 1.49 ng/dl.The result of 1.49 ng/dl was reported outside the laboratory.Information concerning if the patient was adversely affected was requested, but was not provided.It was noted the customer was not using the recommended sample tube rack adapters which may have allowed the sample tube to lean in the rack and cause a pipetting issue.Based on the provided data, no general analyzer issue was indicated.

Manufacturer Narrative

A sample from the patient was submitted for investigation and a streptavidin interference factor was detected.This interference is documented 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: 5127543
• MDR Text Key: 27466475
• Report Number: 1823260-2015-04284
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/10/2015

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 Expiration Date: 03/31/2016
• Device Catalogue Number: 06437281190
• Device Lot Number: 184927
• 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: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• 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: 057 YR