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 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable elecsys ft4 ii assay and elecsys tsh assay results for one patient from cobas 6000 e 601 module serial number (b)(4).This medwatch is for the ft4 assay.Refer to the medwatch with patient identifier pt(b)(4)for the tsh assay.The initial results were ft4 4.10 ng/dl and tsh 1.0 ui/ml.The same sample was retested on (b)(6) 2016 and the results were ft4 5.36 ng/dl and tsh 0.969 ui/ml.Both results were released to the physician, who reported that the ft4 results did not match the clinical condition of the patient.The same sample was sent to another laboratory using an abbott analyzer.The results were ft4 1.42 ng/dl and tsh 0.72 ui/ml.The patient was not adversely affected.

Manufacturer Narrative

Sample from the patient was submitted for investigation and the customer's results were confirmed.An interfering factor to streptavidin was found in the sample which most likely caused the falsely elevated result for the ft4 assay.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 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: 6192705
• MDR Text Key: 62922570
• Report Number: 1823260-2016-02030
• 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: Initial,Followup
• Report Date: 02/07/2017

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: 07/31/2017
• Device Catalogue Number: 06437281190
• Device Lot Number: 168540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• 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: 13 YR