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 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of questionable roche diagnostics cobas elecsys anti-tpo results for 16 patient samples.Of the data provided, there were discrepant anti-tpo results for 1 patient sample on the elecsys e170 modular analytics immunoassay analyzer with reagent lot 34258400 and the cobas 8000 e 801 module with reagent lot 36891100.The customer was validating the e 801 module.It could not be confirmed if the data was being used for diagnostic purposes.Clarification has been requested but the customer was not available.This medwatch will cover the questionable results on the e170 with reagent lot 34258400.Refer to medwatch with patient identifier (b)(6) for information on the questionable results from the e 801 with reagent lot 36891100.The initial anti-tpo result was 43 iu/ml on the e170 modular and was reported outside of the laboratory.The repeat result was 23.5 iu/ml on the e 801 module.There was no information provided to reasonably suggest that there were any adverse events.Clarification has been requested.It was not clear which e170 modular serial number was used.The e170 serial numbers provided were (b)(4).Clarification has been requested but the customer was not available.

Manufacturer Narrative

Based on the available data, a general reagent issue could most likely be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8669667
• MDR Text Key: 147051385
• Report Number: 1823260-2019-02067
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 07/22/2019

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 Expiration Date: 05/31/2019
• Device Catalogue Number: 06368590190
• Device Lot Number: 34258400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 07/22/2019
• 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