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

Catalog Number 04491734190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

The e602 module serial number was (b)(6).

Event Description

The initial reporter complained of discrepant low results for 2 patient samples tested for tpsa on a cobas 8000 e 602 module.On (b)(6) 2024 patient 1 initial result was < 0.014 ng/ml.The initial result was reported outside of the laboratory where it was questioned by the physician.The repeat result was 4.5 ng/ml.The repeat result was believed to be correct and an amended report was provided to the physician.On (b)(6) 2024 patient 2 initial result was 0.015 ng/ml.The repeat result was 7.13 ng/ml.The questionable result for patient 2 was not reported outside of the laboratory.Two additional tpsa results were provided from (b)(6) 2024: 7.06 ng/ml and 7.20 ng/ml.Clarification on these results has been requested but has not been provided.

• 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): 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: 18807314
• MDR Text Key: 336556165
• Report Number: 1823260-2024-00593
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P990056
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04491734190
• Device Lot Number: 708231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• 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