MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; TOTAL PROSTATE SPECIFIC ANTIGEN

Catalog Number 08791686190

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

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys total psa on a cobas e411 rack.The sample initially resulted in a total psa value of 0.012 ng/ml.The clinician questioned the value.The sample was repeated, resulting in a value of 6.370 ng/ml.A serum tube collected at the same time resulted in a value of 6.370 ng/ml.A second sample collected from the patient resulted in a total psa value of 6.370 ng/ml.

Manufacturer Narrative

The serial number of the e411 analyzer is (b)(6).The field service engineer checked the instrument and confirmed there were no issues with the operation.The mixer, probes, and timing belt were checked.The gripper was cleaned.Performance testing was run and there were no problems.The engineer noted that the sample tube position was high.The customer noted that some users would loosely insert sample tubes.The investigation is ongoing.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TOTAL PSA
• Type of Device: TOTAL PROSTATE SPECIFIC ANTIGEN
• 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: 18049759
• MDR Text Key: 328028573
• Report Number: 1823260-2023-03496
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P990056
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791686190
• Device Lot Number: 708237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• 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