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 Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

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 two samples from the same patient tested for roche diagnostics cobas elecsys anti-tpo (anti-tpo) and the elecsys tsh assay (tsh) on an e411 analyzer.Of the two samples, one had erroneous results that were reported outside of the laboratory for anti-tpo and tsh.This medwatch will refer to anti-tpo.Please refer to the medwatch with (b)(6) for information related to tsh.The sample initially resulted as 2.19 miu/l for tsh and 47.73 iu/ml for anti-tpo when tested on the e411 analyzer.The sample was tested on a siemens immulite analyzer, resulting as 1.635 uiu/ml for tsh and < 10 iu/ml for anti-tpo (normal reference range is less than 35 iu/ml).The results were released to the patient along with the suggestion to perform a new measurement in another laboratory.The patient was not adversely affected.The e411 analyzer serial number was (b)(4).During investigations, it was stated that the anti-tpo cut-off value is higher than the normal cut-off, so the anti-tpo result from (b)(6) 2016 can be considered to be negative.The absolute values of measurement results achieved with assays from different vendors cannot always be directly compared as each assay has different standardization procedures and different setups (antibodies used and other components).

Manufacturer Narrative

A general reagent issue at customer site can most likely be excluded.It was noted that the normal reference ranges for pregnancy should be taken into account for this event.The cut-off value for pregnant women is higher than the normal cut-off.

• 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: 5979718
• MDR Text Key: 55725290
• Report Number: 1823260-2016-01469
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• 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: 188439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• 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: CLEXANE; FOLATE; PURAN
• Patient Age: 37 YR