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 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of a questionable elecsys tsh assay result and a questionable elecsys ft4 ii assay result for 1 patient sample tested on a cobas 8000 e 801 module compared to the results from an architect analyzer and a siemens centaur analyzer.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer's cobas e801 serial number was not provided.The cobas e801 serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used at the investigation site was 265662 with an expiration date of feb-2019.The investigation is currently ongoing.

Manufacturer Narrative

The customer's cobas e801 serial number was (b)(4).The investigation determined that a general reagent issue can most likely be excluded.The noticed discrepancies for tsh and ft4 ii between the cobas e801 results versus the competitor systems is likely explained by the fact that the 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 and the standardization methodology used.

Manufacturer Narrative

Na.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7785797
• MDR Text Key: 117294240
• Report Number: 1823260-2018-02729
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2018

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: 07027397190
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 07/30/2018
• Supplement Dates FDA Received: 08/23/2018; 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1