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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received questionable results for a total of 5 samples from the same patient tested for elecsys ft3 iii (ft3), the elecsys ft4 assay (ft4), and the elecsys tsh assay (tsh) on an e602 analyzer.All 5 samples had erroneous results for ft3 and ft4 that were reported outside of the laboratory.Of the 5 samples, two had erroneous tsh results that were reported outside of the laboratory.The results did not match results from a 6th sample from the same patient that was tested on an abbott analyzer at a different site.This medwatch will apply only to ft4.Please refer to the medwatch with patient identifier (b)(6) for information related to ft3 and refer to the medwatch with patient identifier (b)(6) for information related to tsh.Refer to the attachment for patient data.Samples 1 through 5 were tested on the e602 analyzer at the customer site.Sample 6 was tested at a different site on an abbott analyzer.All erroneous results were reported outside of the laboratory.The patient was not adversely affected.The ft3 test was run on e602 serial number (b)(4).The ft4 test was run on e602 serial number (b)(4).The tsh test was run on one of three e602 serial numbers: (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations determined that the sample contains an interferent to the streptavidin used in the ft3 and ft4 reagents.This limitation is covered in product labeling.

• Brand Name: ELECSYS FT4 ASSAY
• 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: 6063484
• MDR Text Key: 58719425
• Report Number: 1823260-2016-01658
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2016
• 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: ALDACTONE ( SPIRONOLACTONE); ALLOPURINOL; DEDROGYL (14 DROPS ON SUNDAY); INEGY; LEVOTHYROX (DAILY); STAGID (1 TABLET 3X); TEMERIT DUO; TRULICITY (DULAGLUTIDE) - 1 INJECTION PER WEEK
• Patient Age: 66 YR