MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number 06368590190

Device Problem High Test Results (2457)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e411 disk serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable anti-tpo elecsys results from the cobas e411 disk analyzer.Patient 1 initial result was 152.5 iu/ml with a data flag.The repeat result on another cobas e411 was 50.68 iu/ml with a data flag and reported outside of the laboratory.The repeat result on the original analyzer was 48.68 iu/ml with a data flag.Patient 2 initial result was 151.2 iu/ml with a data flag.The repeat result on another cobas e411 was 11.54 iu/ml and reported outside of the laboratory.The repeat result on the original analyzer was 13.57 iu/ml.Patient 3 initial result was 341.7 iu/ml with a data flag.The repeat result on another cobas e411 was 19.91 iu/ml and reported outside of the laboratory.The repeat result on the original analyzer was 23.20 iu/ml with a data flag.Patient 4 initial result was 131.4 iu/ml with a data flag.The repeat result on another cobas e411 was 59.11 iu/ml with a data flag and reported outside of the laboratory.The repeat result on the original analyzer was 69.04 iu/ml with a data flag.

Manufacturer Narrative

The field service engineer replaced micro-particle stirrer (bead mixer) due to the higher generation of foam in the reagent.The investigation determined the service actions resolved the issue.

• Brand Name: 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18282355
• MDR Text Key: 329937824
• Report Number: 1823260-2023-03888
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): Y
• Reporter Country Code: CI
• PMA/PMN Number: K051890
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 06368590190
• Device Lot Number: 70815802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1