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

Catalog Number 07027397190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer complained of questionable elecsys tsh assay, elecsys ft4 ii assay, and elecsys ft3 iii results for 1 patient tested on a cobas 8000 e 801 module compared to the results from an abbott architect.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on tsh.Refer to medwatch with patient identifier (b)(6) for information on ft3 iii.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number used as the customer's site is (b)(4).The serial number for the cobas e801 used at the investigation site is (b)(4).The tsh reagent lot used on this cobas e801 was 283556 with an expiration date of feb-2019.The ft4 ii reagent lot used on this cobas e801 was 303203 with an expiration date of apr-2019.The ft3 iii reagent lot used on this cobas e801 was 314824 with an expiration date of may-2019.The investigation determined that in relation to the differences of the tsh and ft3 and ft4 values generated with the analyzers from roche diagnostics and abbott: it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.For the tsh and ft3 and ft4 assays, all generated values ¿ with the analyzers from roche diagnostics and abbott ¿ fit with each other, from a location of these values versus the respective normal reference ranges of the assays.From the information provided and the analysis thereof, a general reagent issue most likely can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8195640
• MDR Text Key: 131494452
• Report Number: 1823260-2018-05097
• Device Sequence Number: 1
• Product Code: CEC
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• 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: 28 YR