MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA); TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number 04641655190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer did not run qc on the total psa reagent pack in question.The investigation is ongoing.

Event Description

The initial reporter questioned results for 47 patient samples tested for elecsys total psa (total psa) on a cobas 8000 e 602 module.Of the data provided, the results for 23 patient samples were discrepant for total psa.Discrepant results for 1 patient sample tested for elecsys free psa (free psa) was also identified.This medwatch will cover total psa.Refer to medwatch with patient identifier (b)(6) for information on the free psa results.Refer to the attached data for the patient results.It is unknown if the patients were prostatectomy or radiotherapy patients.The questionable results were reported outside of the laboratory.The e602 module serial number was (b)(4).

Manufacturer Narrative

Calibration was acceptable.The customer did not handle the reagent according to product labeling: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration." the reagent pack is no longer available for investigation.No sample material is available for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11023790
• MDR Text Key: 244339721
• Report Number: 1823260-2020-03262
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 04641655190
• Device Lot Number: 41934101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1