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

Catalog Number 07026935190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, the elecsys ft4 iii assay, and roche diagnostics cobas elecsys anti-tpo on a cobas 8000 e 801 module.The sample also had an erroneous result for the elecsys ft4 ii assay when tested on a second e 801 analyzer used for investigation.This medwatch will apply to the anti-tpo assay.Please refer to the medwatches with the following.Patient identifiers for information related to each other affected assay: (b)(6) = tsh ; (b)(6) = ft3 ; (b)(6) = ft4 iii ; (b)(6) = ft4 ii.Refer to the attachment for all patient data.The sample was tested on the customer's e 801 analyzer, then tested on abbott architect analyzers at the customer site and another laboratory.The sample was provided for investigation where it was tested on a second e 801 analyzer.Measurements for tsh, ft3, and ft4 iii were performed on the e 801 analyzer used for investigation on (b)(6) 2018.Measurements for ft4 ii and anti-tpo were performed on the e 801 analyzer used for investigation on (b)(6) 2018.No adverse events were alleged to have occurred with the patient.The e 801 analyzer used at the customer site is serial number (b)(4).The e 801 analyzer used for investigation is serial number (b)(4).Anti-tpo reagent lot number 342606, with an expiration date of feb 2019 was used on this analyzer.

Manufacturer Narrative

A sample was investigated by the manufacturer.The sample contained an interferent to a component of the reagent.This is covered in product labeling.The package insert states: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.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: 8032731
• MDR Text Key: 127886166
• Report Number: 1823260-2018-04046
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630939831
• UDI-Public: 4015630939831
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07026935190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR