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 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported questionable results for one patient for thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3).The physician had requested an investigation into the possible effect of dosed drugs.Of the data provided, erroneous ft4 and ft3 results were identified between the customer's e602 analyzer, a siemens centaur analyzer, a mod-pe analyzer used at the investigation site and an e411 analyzer used at the investigation site.It is not known if both of the assays at the customer site were done using samples from the same blood draw.The control values were okay at both the customer site and during the investigation.This medwatch will cover for ft4.Refer to the medwatch with patient identifier pt- (b)(6) for information on the ft3 erroneous results.Refer to the attached mdr data for the patient results.There was no adverse event.The customer's e 602 analyzer and siemens centaur analyzer serial numbers are unknown.The serial number of the mod-pe at the investigation site is (b)(6).The serial number of the e411 at the investigation site is (b)(6).The ft4 reagent lot number for the e411 at the investigation site was (b)(4) with an expiration of 03/01/2017.A specific root cause could not be determined.The results on the e 602 were above the normal reference range for the assay.Those results generated on the siemens centaur and at the investigation unit were within the normal reference range of the assay.The investigation determined that the cause may have been an interference in the sample that would only show up and act differently depending upon the type of analyzer being used.No further investigation can take place as there is not sufficient sample volume.

• 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: 5875220
• MDR Text Key: 52103683
• Report Number: 1823260-2016-01171
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2016

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 Expiration Date: 03/31/2017
• Device Catalogue Number: 06437281190
• Device Lot Number: 140865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/15/2016
• 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
• Treatment: LACTOSEMILK SUGAR
• Patient Age: 34 YR