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 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

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).This medwatch will refer to the anti-tpo assay.Please refer to the medwatch with patient identifier (b)(6) for information related to tsh and to the medwatch with patient identifier (b)(6) for information related to ft4.The sample initially resulted as 1.57 uui/ml for tsh, 2.76 ng/dl for ft4, and 214.1 u/ml for anti-tpo when tested on the e602 analyzer.The sample was repeated at a second laboratory on a beckman analyzer and it resulted as 3.40 uui/ml for tsh, 1.22 ng/dl for ft4, and 2.0 ui/ml for anti-tpo.The sample was also sent to a third laboratory where it was repeated two additional times on rocha analyzers for ft4.The ft4 result from a cobas 8000 e 602 module was 2.62 ng/dl and the ft4 result from a cobas e 411 immunoassay analyzer was 1.99 ng/dl.The patient was not adversely affected.The serial number of the customer's e602 analyzer was (b)(4).The serial numbers of the cobas 8000 e 602 module and cobas e 411 immunoassay analyzer used at the third laboratory were asked for, but not provided.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample have determined that it contains an interferent to the tsh, ft4, and anti-tpo assays.This limitation is covered in product labeling.

• 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: 6304102
• MDR Text Key: 66660497
• Report Number: 1823260-2017-00228
• 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
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

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?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• 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
• Patient Age: 3 YR