MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS COBAS E 200 V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number 08429324190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable elecsys ft4 iii and assay elecsys tsh assay results for 1 patient tested on a cobas 8000 e 602 module compared to an abbott system.The customer believes that an interferant is affecting the results.This medwatch will cover tsh.For information on ft4 iii refer to the medwatch with patient identifier (b)(6).The cobas e602 results were ft4 iii 30.31 pmol/l and tsh 3.91 mu/l.The abbott results were ft4 20.3 pmol/l and tsh 2.25 mu/l.The customer also noted that the patient's ft4 results have been elevated since "2018." the results in question were reported outside of the laboratory.The cobas e602 serial number is (b)(4).

Manufacturer Narrative

The customer returned a plasma sample and a serum sample for investigation.The investigation on the serum sample was able to reproduce the customer¿s results.The sample was tested for interference, but no interfering factors were found.The differences in the tsh values, generated with the analyzers from roche diagnostics and abbott, are caused by differences of the setups of the assays, the antibodies used, and differences of the standardization materials and procedures used.A product problem was not identified.

• Brand Name: TSH ELECSYS COBAS E 200 V2
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8921149
• MDR Text Key: 176644472
• Report Number: 1823260-2019-03090
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

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: 08429324190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALPHAGAN/LUMIGAN EARDROPS; COSOPT EARDROPS; ELTHYRONE (1/DAY); SIMVASTAINE (1/DAY); SOTALOT