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 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable thyroid results for an unknown number of patient samples from two cobas e602 analyzers when compared to the results from competitor reagents.The customer suspected that interferences in the samples may have been the cause.Of the data provided for six patient samples, only the results for five of the samples were discrepant.Clarification of the specific dates of testing was requested, but was not provided.Refer to the attachment to the medwatch for all patient data.This medwatch is for free thyroxine (ft4) for patients 2-5.Refer to the medwatch's with (b)(6) for the other reagent lot numbers and assays involved in the complaint.Information regarding if any erroneous result was reported outside the laboratory was requested, but it was unknown.The patients were not adversely affected.

Manufacturer Narrative

Samples for patients 2 and 3 were submitted for further investigation.Initial investigation of the samples confirmed there was an immunoglobulin that reacts with the reagent.An interfering factor to streptavidin was identified in the samples.These interfering factors are documented in product labeling for the assay.No product problem could be found.

• 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: 5882129
• MDR Text Key: 52322054
• Report Number: 1823260-2016-01212
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2016

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: 14086500
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• 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