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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for twenty one patient samples tested for the elecsys tsh assay (tsh), elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), roche diagnostics cobas elecsys anti-tpo (anti-tpo), and the elecsys anti-tshr immunoassay (anti-tshr) on a cobas 6000 e 601 module.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.(b)(4).Refer to the attachment for all patient data.The erroneous values are highlighted in yellow.The samples were tested on the e601 analyzer and repeated using the delfia and siemens immulite 2000 xpi methods.No adverse events were alleged to have occurred with the patients.The e601 analyzer serial number is (b)(4).

Manufacturer Narrative

The customer provided corrected data for patient sample 14.The customer also provided data for 5 additional patient samples that were affected (samples 22 - 26).Refer to the attachment for all data.The highlighted results are erroneous.It was asked, but it is not known if any erroneous results were reported outside of the laboratory for these samples.No adverse events were alleged to have occurred with the patients.(b)(6).

Manufacturer Narrative

The patient samples were provided for investigation.Investigations of sample 17 determined that it contained an interferent to a component of the anti-tpo assay.This limitation is covered in product labeling.An interfering factor could not be identified in samples 18 and 19.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: 7380682
• MDR Text Key: 104039615
• Report Number: 1823260-2018-00941
• Device Sequence Number: 0
• 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,Followup
• Report Date: 06/19/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1