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 11/03/2014

Event Type  malfunction  

Event Description

The customer reported that they received an implausible high result for one patient sample tested for free thyroxine (ft4).The high result did not match the patient's clinical history.On (b)(6) 2013, a sample from the patient had results of 1.05 ng/dl for ft4 (indicated as euthyroid), 2.84 pg/ml for free triiodothyronine (ft3) (indicated as euthyroid), and 5.05 uiu/ml for thyrotropin (tsh) (indicated as hypothyroid).On (b)(6) 2013, a sample from the patient had results of 1.06 ng/dl for ft4 (indicated as euthyroid), 2.66 pg/ml for ft3 (indicated as euthyroid), and 2.68 uiu/ml for tsh (indicated as hypothyroid).On (b)(6) 2014, a sample from the patient had results of >7.77 ng/dl for ft4 (indicated as hyperthyroid), 4.69 pg/ml for ft3 (indicated as hyperthyroid), and 0.77 uiu/ml for tsh (indicated as euthyroid).The ft4 result was reported to the physician, who questioned the result since it did not fit the patient's clinical situation.The patient was not adversely affected as the physician did not take any actions based on the high result.The e411 disk analyzer which was used to generate the high ft4 result, has a serial number of (b)(4).The complained sample was provided for investigation.Investigations have been able to reproduce the high ft4 result seen at the customer site.The sample was investigated for potential streptavidin interference, but no interference to streptavidin was detected in the sample.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

No interfering factor was identified in the sample during the investigation.The high ft4 result was confirmed on a siemens centaur analyzer.

• 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: 4280457
• MDR Text Key: 5229639
• Report Number: 1823260-2014-09384
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/29/2014

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: 179279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2014
• 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: TRYPTOPHAN - 1 TIME DAILY; VITAMIN B12 DROPS - DAILY; L-THYROXIN - 1 TIME DAILY; FERRO SANOLDUODENAL - 1 TIME DAILY; CEFASEL 200 NUTRI - 1 TIME DAILY; DEKRISTOL 20.000 - 1 TIME EACH THIRD DAY