MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA IMMUNOASSAY; TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number 04491734190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for two samples from the same patient tested with the elecsys free psa immunoassay and the elecsys total psa immunoassay on a cobas 8000 e 602 module.The free psa values were larger than the total psa values.The test results were reported outside of the laboratory to the patient.This medwatch will apply to the total psa assay.Please refer to the medwatch with the patient identifier (b)(6) for information related to the free psa assay.The first sample was tested twice using the free psa assay, resulting with values of 1.05 ng/ml and 1.03 ng/ml.This sample was tested twice using the total psa assay, resulting with values of 0.110 ng/ml and 0.094 ng/ml.The second sample was tested using the free psa assay on (b)(6) 2020, resulting with a value of 1.13 ng/ml.This sample was repeated using the free psa assay on (b)(6) 2020, resulting with a value of 1.12 ng/ml.This sample was tested using the total psa assay on (b)(6) 2020, resulting with a value of 0.096 ng/ml.This sample was repeated using the total psa assay on (b)(6) 2020, resulting with a value of 0.087 ng/ml.The serial number of the e 602 analyzer is (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation and the results obtained by the customer could be reproduced.No evidence of an interfering substance was found in the sample.Further investigations determined there was evidence the sample contains a seldom psa-isoform that cannot be completely detected by the usage of the standard total psa assay.Per product labeling: "it is known that in rare cases psa isoforms do exist which may be measured differently by different psa tests.Findings of this kind have occasionally been reported for psa tests from various manufacturers." a general reagent issue could be excluded.The investigation did not identify a product problem.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• 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: 10546966
• MDR Text Key: 207354327
• Report Number: 1823260-2020-02285
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04491734190
• Device Lot Number: 409527
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR