MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number ASKU

Device Problem Incorrect Measurement (1383)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys free psa and elecsys total psa on a cobas e 801 analytical unit.This medwatch will apply to the total psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the free psa assay.The sample resulted in free psa values of 0.205 ng/ml and 0.206 ng/ml when tested on the e 801 analyzer.The sample was tested on a second analyzer, resulting in a free psa value of 0.0747 ng/ml.The 0.0747 ng/ml value agreed with the patient's previous results.The sample resulted in a total psa value of 0.195 ng/ml when tested on the e801 analyzer.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The reagent performed within specifications and a general reagent-related issue could be excluded.

• Brand Name: ELECSYS TOTAL PSA
• Type of Device: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• 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 46250-0457
• MDR Report Key: 18182708
• MDR Text Key: 328680617
• Report Number: 1823260-2023-03730
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P000027
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 749832
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• 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