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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), and the elecsys tsh assay (tsh) on a cobas e 411 immunoassay analyzer (e411).The customer complained of the discrepancy between the e411 ft3 results and the ft3 result from an architect analyzer.This medwatch will apply to the ft4 assay.Please refer to the medwatch with (b)(6) for information related to the ft3 assay and refer to the medwatch with (b)(6) for information related to the tsh assay.A sample from the patient was initially tested for ft3 and ft4 on the e411 analyzer.The physician did not believe the ft3 result, so he asked for a repeat of all the tests on the e411 analyzer.The customer repeated the sample on the e411 analyzer and also repeated the sample in a different laboratory using the architect analyzer.No adverse events were alleged to have occurred with the patient.Quality controls tested on the e411 analyzer were within acceptable ranges.No abnormalities were observed with calibration or controls.The e411 analyzer serial number was (b)(4).Based on the calibration and control data, a general reagent issue can most likely be excluded.A sample from the patient was not available, so no further investigation was possible.An interfering factor may be present in the sample, which affects either the measurements of the e411 analyzer or architect analyzer.

• Brand Name: ELECSYS FT4 II 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: 6960823
• MDR Text Key: 90675354
• Report Number: 1823260-2017-02368
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K131244
• 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
• Report Date: 10/19/2017

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: ASKU
• Device Lot Number: 185414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/19/2017
• 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