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

Model Number E602

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: asku.This event occurred in (b)(6).

Event Description

The customer received questionable elecsys ft4 ii assay results for one patient and suspected there was antibody interference as the ft4 result was very high with a normal tsh result.Multiple samples from the patient were tested on different analyzers.Of the data provided, the results for ft4, tsh, ft3, tpo, and total t4 were discrepant.Refer to the attachment to the medwatch for all patient data.The results were reported to the clinicians.The patient was not adversely affected.The reagent lot numbers and expiration dates were requested, but were not provided.A specific root cause could not be identified.The age of the only sample from the patient that was available for further investigation was past the stated stability of the analyte.From the information provided, a general reagent was not detected.

Manufacturer Narrative

Data for additional samples from the patient was received.Refer to the attachment to the medwatch.On (b)(4) 2016, the tsh reagent lot used was 185522.The anti-tpo reagent lot used was 165776.Samples from the patient drawn on (b)(4) 2016 were submitted for investigation.

Manufacturer Narrative

Investigation of the provided patient samples found an interfering factor to streptavidin was present.This interference is documented in product labeling for the assays.Additional assays were involved in the complaint.For these assays, the manufacturer fields were identical to the ft4, free thyroxine assay.For the tsh assay: elecsys tsh assay, radioimmunoassay, thyroid-stimulating hormone, jlw, catalog no: asku, lot #: 185522, expiration date: asku, k961491, udi: (b)(4).For the ft3 assay: elecsys ft3 iii, radioimmunoassay, total triiodothyronine, cdp, catalog no: asku, date: asku, exempt, udi: (b)(4).For the tpo assay: roche diagnostics cobas elecsys anti-tpo, system, test, thyroid autoantibody, jzo, catalog no: asku, lot #: asku, expiration date: asku, k051890, udi: (b)(4).For the t4 assay: elecsys t4 assay, radioimmunoassay, total thyroxine, cdx, catalog no: asku, lot #: asku, expiration date: asku, k961490, udi: (b)(4).

• 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: 5989839
• MDR Text Key: 56001908
• Report Number: 1823260-2016-01499
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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
• Report Date: 02/10/2017

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 Model Number: E602
• Device Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2017; 02/10/2017
• 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