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

Catalog Number 08496609190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

Calibration was acceptable.Qc was acceptable.Two "sample volume insufficient" or "clot pipetting" errors were observed on the alarm trace data.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant high results for 2 patient samples tested for elecsys anti-tshr (anti-tshr) on a cobas e 411 immunoassay analyzer.Patient 1 initial result was > 40 iu/l.The sample was repeated twice with results of 2.11 iu/l and 2.34 iu/l.Patient 2 initial result was > 40 iu/l.The sample was repeated twice with results of 5.15 iu/l and 5.05 iu/l.No questionable results were reported outside of the laboratory.The e411 analyzer serial number was (b)(4).

Manufacturer Narrative

From the information provided, a general reagent issue could be excluded.The specific cause of the event could not be determined.The investigation determined the event was consistent with a pre-analytical handling issue.

• Brand Name: ELECSYS ANTI-TSHR
• Type of Device: THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16501014
• MDR Text Key: 310856712
• Report Number: 1823260-2023-00721
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 07613336160305
• UDI-Public: 07613336160305
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K193313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 08496609190
• Device Lot Number: 61765100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• 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