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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they had questionable results for two patient samples tested for thyroid, bone, and fertility tests.When the samples were tested on the cobas e602 analyzer, these results did not match results when tested on an abbott architect i2000sr analyzer.The samples were also treated with heterophile blocking tubes (hbt) from scantibodies and lower results were found for several tests.Treatment with the hbt showed interference for all thyroid tests as well as other analytes.Turbidometric tests did not seem to be affected.The two patient samples were found to have erroneous results for free triiodothyronine (ft3), free thyroxine (ft4), thyrotropin (tsh), and thyroxine (t4).Only the results for ft3, ft4, and tsh were determined to be a reportable malfunction.The results were reported outside of the laboratory to the doctors for the first patient sample.For the second patient sample, the results were not reported outside of the laboratory and the requesting physician was informed of sample interference.This medwatch will cover ft4.Refer to the medwatch with (b)(6) for information referring to ft3.Refer to the medwatch with (b)(6) for information referring to tsh.The first patient sample initially resulted as 10.6 pmol/l for ft3, 56 pmol/l for ft4, and 0.621 mui/l for tsh.When the sample was treated with the hbt tube and tested on the cobas e602 analyzer, the sample resulted as 4.5 pmol/l for ft3, 20 pmol/l for ft4, and 1.02 mui/l for tsh.When tested on an abbott architect i2000sr analyzer, the sample resulted as 14 pmol/l for ft4 and 0.741 mui/l for tsh.When the sample was treated with the hbt tube and tested on the abbott architect i2000sr analyzer, the sample resulted as 14 pmol/l for t4 and 0.746 mui/l for tsh.The second patient sample, from a (b)(6), initially resulted as 13.4 pmol/l for ft3, 70 pmol/l for ft4, and 1.99 mui/l for tsh on (b)(6) 2015.When the sample was treated with the hbt tube and tested on the cobas e602 analyzer, the sample resulted as 4.6 pmol/l for ft3, 18 pmol/l for ft4, and 3.34 mui/l for tsh.When tested on an abbott architect i2000sr analyzer, the sample resulted as 14 pmol/l for t4 and 2.15 mui/l for tsh.When the sample was treated with the hbt tube and tested on the abbott architect i2000sr analyzer, the sample resulted as 15 pmol/l for t4 and 2.21 mui/l for tsh.The first patient received a thyroid ultrasonography based on the erroneous results, but both patients were not adversely affected.The cobas e602 analyzer serial number was (b)(4).

Manufacturer Narrative

The patient samples were provided for investigation.Investigations determined that there was the presence of an igm-type interference factor in the samples and this interfered with the streptavidin present in the reagent.This interfering factor reduces the signal read out, thereby causing higher values for the ft3 and ft4 assays and lower values for the tsh assay.This type of 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: 5107425
• MDR Text Key: 26899943
• Report Number: 1823260-2015-04224
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 10/06/2015

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: 09/28/2018
• Device Catalogue Number: 06437281190
• Device Lot Number: 00000
• 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: 09/28/2015
• 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: 064 YR