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 06/22/2015

Event Type  malfunction  

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample have determined that an interfering factor to streptavidin this interference is covered by a disclaimer in product labeling.

Event Description

The customer reported that they received erroneous results for two patient samples tested for free thyroxine (ft4).The results were considered to be very high because the tsh result for each patient sample was around 1 miu/l.The samples were tested initially on an e602 analyzer.The samples were repeated on a different e602 analyzer and results between the two systems were said to be comparable.The samples were then sent to the customer's main laboratory where they were tested on a siemens advia centaur analyzer.Results were lower on the centaur system and said to be reasonable.The samples were also later tested at a different laboratory on an e601 system.Results on the e601 system were comparable to the e602 system results.This medwatch will cover ft4 reagent lot number 184927.Patient identifier (b)(6) for information related to ft4 reagent lot number 183473.The first patient sample initially resulted as >100 pmol/l on e602 analyzer system 1.The erroneous result was reported outside of the laboratory and was refused by the physician, because it did not correlate with other thyroid parameters.The sample was repeated on e602 analyzer system 2, resulting as 51.85 pmol/l.The sample was sent to a reference laboratory where it was tested on a siemens advia centaur analyzer, resulting as 15.81 pmol/l.The sample was sent to another laboratory where it was repeated again on an e601 analyzer, resulting as >100 pmol/l.The second patient sample, from a (b)(6), initially resulted as 86.87 pmol/l on e602 analyzer system 1.The erroneous result was reported outside of the laboratory and was refused by the physician, because it did not correlate with other thyroid parameters.The sample was repeated on e602 analyzer system 2, resulting as 64.4 pmol/l.The sample was sent to a reference laboratory where it was tested on a siemens advia centaur analyzer, resulting as 19.66 pmol/l.The sample was sent to another laboratory where it was repeated again on an e601 analyzer, resulting as 89.24 pmol/l.The patients were not adversely affected.The e602 analyzer system 1 was serial number (b)(4).Ft4 reagent lot number 183473, with an expiration date of january 2016 was used on this system.The e602 analyzer system 2 was serial number 1162-07.Ft4 reagent lot number 183473, with an expiration date of january 2016 was used on this system.The e601 analyzer was serial number (b)(4).Ft4 reagent lot number 184927, with an expiration date of march 2016 was used on this system.

Manufacturer Narrative

This event occurred in (b)(6).

• 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) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4914965
• MDR Text Key: 13712155
• Report Number: 1823260-2015-03803
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• 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: 184927
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 06/29/2015
• 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
• Patient Sequence Number: 1
• Treatment: EUTHYROX (5X/WEEK) - PATIENT 2; LETROX (4X/WEEK)- PATIENT 1
• Patient Age: 032 YR