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 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable thyroid results for one patient sample from cobas e601 serial number (b)(4).Of the data provided, only the results for ft4 and ft3 were discrepant.The result from a sample on (b)(6) 2016 were: elecsys ft4 ii assay 80.2 pmol/l, elecsys ft3 iii 17.07 pmol/l, elecsys tsh assay 0.31 mu/l.On (b)(6) 2016, a new sample was drawn and the results were: ft4 > 100 pmol/l, ft3 18(17.88) pmol/l, tsh 0.49 iu/l.After consulting with an endocrinologist, the sample was also tested on an abbott analyzer and the results were: ft4 17.3 pmol/l, ft3 4.23 pmol/l.A possible interference by heterophilic / blocking antibodies was suspected.Information regarding if any erroneous result was reported outside the laboratory was requested but it was unknown.The patient was not adversely affected.Sample from the patient was submitted for investigation.Refer to the medwatch with patient identifier (b)(6) for the other assay involved.

Manufacturer Narrative

The provided sample was investigated and an interfering factor to streptavidin was detected.This interference most likely caused the event and 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: 6046277
• MDR Text Key: 58055759
• Report Number: 1823260-2016-01601
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 11/14/2016

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: 158223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2016
• 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: 16 YR