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 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received high results for one patient sample tested for free triiodothyronine (ft3) and free thyroxine (ft4).The sample in question was tested on (b)(6) 2015.The results from a cobas 8000 "e" analyzer were higher when compared to results from an architect analyzer.The erroneous results were reported outside of the laboratory.This medwatch will cover ft4.(b)(6) for information related to ft3.Initially, a sample from the patient was tested on (b)(6) 2015 on an e module analyzer, resulting as 4.0 pmol/l for ft3 and 15 pmol/l for ft4.A second sample from the patient was tested on (b)(6) 2015 on the cobas 8000 "e" analyzer at the customer site, resulting as 11.8 pmol/l for ft3 and 49 pmol/l for ft4.These results were said to be elevated.A third sample from the patient was tested on (b)(6) 2015 at a second site on an e module analyzer, resulting as 12.1 pmol/l for ft3 and 46 pmol/l for ft4.A fourth sample from the patient was tested on (b)(6) 2015 on the customer's cobas 8000 "e" analyzer, resulting as 11.4 pmol/l for ft3 and 46 pmol/l for ft4.Results for this sample were said to be elevated.A fifth sample from the patient was tested on (b)(6) 2015 on the customer's cobas 8000 "e" analyzer, resulting as 10.3 pmol/l for ft3 and 56 pmol/l for ft4.A sixth sample from the patient was tested on (b)(6) 2015 on a delfia analyzer at a third site, resulting as 5.1 pmol/l for ft3 and 15.4 pmol/l for ft4.Since the results from the sixth sample appeared to be different than what previous samples recovered, the next sample was checked using two different methods.This seventh sample from the patient was tested on (b)(6) 2015 on the customer's cobas 8000 "e" analyzer, resulting as 11.0 pmol/l for ft3 and 56 pmol/l for ft4.A second tube from the same sample collection was also tested on an architect analyzer at the third site, resulting as 3.8 pmol/l for ft3 and 15 pmol/l for ft4.The patient was not adversely affected.The customer's cobas 8000 core unit serial number was (b)(4).It was asked, but it is not known what the serial number was for the associated cobas 8000 "e" analyzer.

Manufacturer Narrative

The units of measure used for the tsh assay are miu/l.A new sample was collected from the patient and tested on (b)(6) 2015.The sample was tested on the cobas 8000 analyzer, resulting as 0.92 miu/l for tsh, 43 pmol/l for ft4, and 8.8 pmol/l for ft3.The sample was also sent to the third site for testing on the architect analyzer on (b)(6) 2015, resulting as 77 nmol/l for t4, 15 pmol/l for ft4, 1.6 nmol/l for t3, and 4.2 pmol/l for ft3.No adverse events were alleged to have occurred.

Manufacturer Narrative

Two samples from the patient were provided for investigation.Investigation of the samples determined that there was an interfering factor present in the samples which interferes with the streptavidin present in the ft3 and ft4 reagents.This limitation is covered 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: 5171916
• MDR Text Key: 29215406
• Report Number: 1823260-2015-04383
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,Followup
• Report Date: 11/30/2015

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: 12345
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/28/2015; 11/03/2015; 11/30/2015
• 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