MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E-ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM

Catalog Number 04388780190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

The customer received an implausible high anti-tshr (antibodies to tsh receptor) result for one patient sample from a cobas e602 analyzer.The results provided were: anti-tshr: 5.2 iu/l t4: 129.4 nmol/l t3: 2.8 nmol/l ft3: 4.7 pmol/l ft4: 12 pmol/l tsh: 0.94 miu/l information concerning if any erroneous result was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.The sample was submitted for investigation and the ft4 and ft3 results were within the reference ranges.No interference to streptavidin could be found in the sample.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• Brand Name: COBAS E-ELECSYS ANTI-TSHR
• Type of Device: THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4918838
• MDR Text Key: 6056052
• Report Number: 1823260-2015-03812
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K080092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2015

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: 04388780190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 07/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2015
• 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
• Patient Sequence Number: 1