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

Catalog Number 08791686190

Device Problems Incorrect Measurement (1383); Insufficient Information (3190)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

The customer used a new reagent and calibrator for total psa and now everything is ok.

Event Description

The initial reporter stated they received questionable results for four patients tested with the elecsys total psa immunoassay ver.3 and the elecsys free psa immunoassay on a cobas e 411 immunoassay analyzer.The free psa values were greater than the total psa values.No incorrect results were reported outside of the laboratory.The customer noted the issue occurs only for post surgery patients.Healthy patient results are ok.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 first sample resulted in a total psa value of < 0.006 ng/ml when tested on the e411 analyzer and resulted in a value of 0.270 when tested on a siemens analyzer.This sample resulted in a free psa value of 0.02 ng/ml when tested on the e411 analyzer and resulted in a value of 0.089 ng/ml when tested on a siemens analyzer.The second sample resulted in a total psa value of < 0.006 ng/ml when tested on the e411 analyzer and resulted in a value of 0.092 when tested on a siemens analyzer.This sample resulted in a free psa value of 0.08 ng/ml when tested on the e411 analyzer and resulted in a value of 0.07 ng/ml when tested on a siemens analyzer.On (b)(6) 2022, the third sample resulted in a total psa value of 0.104 ng/ml when tested on the e411 analyzer and resulted in a value of 0.425 when tested on a siemens analyzer.This sample resulted in a free psa value of 0.209 ng/ml when tested on the e411 analyzer and resulted in a value of 0.177 ng/ml when tested on a siemens analyzer.On (b)(6) 2022, the fourth sample resulted in a total psa value of < 0.006 ng/ml when tested on the e411 analyzer and resulted in a value of 0.177 when tested on a siemens analyzer.This sample resulted in a free psa value of 0.231 ng/ml when tested on the e411 analyzer and resulted in a value of 0.209 ng/ml when tested on a siemens analyzer.The serial number of the e411 analyzer (b)(4).

Manufacturer Narrative

The last free psa and total psa calibrations on 14-jun-2022 had lower than expected signals for the second calibrator level.Alarm trace data was provided, but did not cover the day of the event.There were many alarms indicating that cleaning maintenance needed to be performed.The customer replaced the reagent pack and calibrator material.Calibration and control were within range.No further issues occurred after this action.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15229111
• MDR Text Key: 305352210
• Report Number: 1823260-2022-02451
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: BK
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• 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: 614949
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• 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