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 Consequences Or Impact To Patient (2199)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for the elecsys tsh assay (tsh), the elecsys ft4 ii assay (ft4), and roche diagnostics cobas elecsys anti-tpo (anti-tpo) on a cobas 8000 e 602 module (e602).Dates of (b)(6) 2016 were provided as the date of the event.A clarification has been requested.This medwatch will cover anti-tpo.Please refer to the medwatch with patient identifier (b)(6) for information related to tsh and refer to the medwatch with patient identifier (b)(6) for information related to ft4.The sample initially resulted as 0.03 mu/l for tsh, 2.60 ng/dl for ft4, and 171.90 u/ml for anti-tpo when tested on the e602 analyzer.The initial results were reported outside of the laboratory to medical personnel.The sample was repeated on an abbott analyzer, resulting as 0.83 uui/ml for tsh, 1.0 ng/dl for ft4, and negative (below 34 iu/ml) for anti-tpo.The patient was not adversely affected.The serial number of the used e602 analyzer was asked for, but not provided.Calibration and controls were said to be good and there was no issue with any other sample results.

Manufacturer Narrative

The correct date of event has been confirmed as (b)(6) 2016.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations determined that the sample contains a high biotin concentration, which is above the allowable biotin concentration mentioned in labeling for the tsh, ft4, and anti-tpo assays.This high level of biotin most likely caused the tsh, ft4, and anti-tpo result discrepancies.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6193854
• MDR Text Key: 62972448
• Report Number: 1823260-2016-02035
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K051890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2017

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/28/2016; 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: D-BIOTIN (3 TIMES PER DAY)