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

Catalog Number 07976836190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned results for 3 patients tested for elecsys ft4 iii (ft4 iii), elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) on a cobas 6000 e 601 module.The initial results were reported outside of the laboratory and the customer requested an investigation of the patient samples.Based on the data provided, discrepant results were identified for all 3 patients tested for ft4 iii, tsh, ft4 ii and ft3 iii between the customer's e601 module, a cobas 8000 e 602 module used at the investigation site and the abbott architect method.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results, medwatch with patient identifier (b)(6) for information on the ft4 ii results and medwatch with patient identifier (b)(6) for information on the ft3 iii results.Refer to attached data for the patient results, age and gender.There was no allegation that an adverse event occurred.The customer's e601 module serial number was (b)(4).The e602 module serial number used at the investigation site was (b)(4).The ft4 iii reagent lot number used at the investigation site was 304692 with an expiration date of jan-2019.Calibration and qc data at the investigation site was ok.There was not enough sample material remaining to complete the investigation.Based on the information provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case abbott can generate different results due to the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.The investigation was unable to find a definitive root cause.

• Brand Name: ELECSYS FT4 III 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: 7794465
• MDR Text Key: 117615174
• Report Number: 1823260-2018-02764
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336153956
• UDI-Public: 7613336153956
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/17/2018

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: 07976836190
• Device Lot Number: 331797
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/17/2018
• 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
• Patient Age: 84 YR