MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number 08791686160

Device Problem Low Test Results (2458)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There was an allegation of a questionable low total psa elecsys result from the cobas e411 rack analyzer.The initial result was < 0.01 ng/ml with a data flag and the repeat result was 6.02 mg/dl.The physician questioned the initial result as it did not meet the clinical picture of the patient.The repeat result was believed correct.

Manufacturer Narrative

Medwatch fields d1-d4, g2, and g4 were updated.As the qc recovery was within -2sd, there was no indication of a performance issue with the reagent.The field service engineer replaced the syringe seals and pinch tubing.He ran a system volume check and performance testing that passed.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS TOTAL PSA
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18720800
• MDR Text Key: 336618848
• Report Number: 1823260-2024-00459
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791686160
• Device Lot Number: 70824201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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