MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number 06368590190

Device Problem High Test Results (2457)

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

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received questionable thyroid results for two samples from the same patient tested for multiple thyroid tests on a cobas 8000 e 602 module (e602).Of the mentioned assays, the sample had erroneous results for the elecsys tsh assay (tsh), the elecsys anti-tshr immunoassay (anti-tshr), and roche diagnostics cobas elecsys anti-tpo (anti-tpo).The erroneous results were reported outside of the laboratory.(b)(4).Based on results measured from a sample collected on (b)(6) 2018, the endocrinologist treated the patient with neomercazole treatment starting on (b)(6) 2018.The patient was started with a 60 mg dose at first and then decreased to 40 mg starting on (b)(6) 2018.The endocrinologist stated that the patient had biological basedow disease with no clinical sign.Refer to the attachment for all patient data.The samples, dated (b)(6) 2018 were tested on the e602 analyzer.These samples were also tested using assays manufactured by siemens and brahms.No adverse events were alleged to have occurred with the patient.The patient does not take a dietary supplement.Normally the patient does not take biotin in high doses.The patient has 2 monoclonal immunoglobulins, 1 igg lambda and 1 iga lambda.The e602 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations determined that the sample contains an interferent to a component of the anti-tpo assay.This limitation is covered in product labeling.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.

• Brand Name: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7377996
• MDR Text Key: 104035004
• Report Number: 1823260-2018-00936
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K051890
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06368590190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLECAINE; INEXIUM; MONOTILDIEM; NEOMERCAZOLE; PERINDOPRIL; PREVISCAN; TAHOR
• Patient Age: 69 YR