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

Catalog Number ASKU

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Event Description

The customer experienced an issue where the elecsys free psa immunoassay results were higher than the elecsys total psa immunoassay results for two samples from one patient.The customer used the cobas e 411 immunoassay analyzer serial number (b)(4).For the initial sample, the free psa result was 5.56 ng/ml and the total psa result was 0.25 ng/ml.The initial sample was repeated.The free psa result was 5.77 ng/ml and the total psa result was 0.23 ng/ml.The initial sample was repeated with an automatic 1:2 dilution.The free psa result was 5.78 ng/ml and the total psa result was 0.27 ng/ml.For the initial sample tested with the abbott method, the free psa result was 0.08 ng/ml and the total psa result was 0.56 ng/ml.On (b)(6) 2018 a new sample was collected from the patient.The free psa result was 5.43 ng/ml and the total psa result was 0.24 ng/ml.No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.This medwatch will cover the total psa results.(b)(4).

Manufacturer Narrative

The patient sample was submitted for investigation.The customer¿s results of free psa and total psa are reproducible and their complaint has been confirmed.The investigation was performed by adding an additional anti-psa antibody of a different specificity and the concentration of total psa was greater than 2.84 ng/ml.The investigation determined that the false low total psa results were due to one or more interfering components.

• Brand Name: TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7503473
• MDR Text Key: 108249969
• Report Number: 1823260-2018-01445
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR