MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FREE PSA TEST SYSTEM; TEST, PROSTATE SPECIFIC ANTIGEN, FREE, (NONCOMPLEXED)

Catalog Number 08828601190

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 08/07/2021

Event Type  malfunction  

Manufacturer Narrative

Common device name = "test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions.".

Event Description

The initial reporter stated they received questionable results for three samples collected from the same patient and tested with the elecsys total psa immunoassay and the elecsys free psa immunoassay on a cobas 6000 e 601 module.The first sample also had questionable total psa and free psa values when tested on a cobas e 411 immunoassay analyzer.The free psa results were larger than the total psa results.This medwatch will apply to the free psa assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the total psa assay.The first sample resulted in a free psa value of 10.20 ng/ml and a total psa value of 0.342 ng/ml accompanied by a data flag on the e 601 analyzer.The sample was diluted (dilution ratio unknown) and repeated on the e 601 analyzer, resulting in a total psa value of 0.282 ng/ml.This sample was repeated on an e411 analyzer on (b)(6) 2021, resulting in a free psa value of 9.54 ng/ml and a total psa value of 0.215 ng/ml.The sample was diluted 1:10 and repeated on the e411 analyzer on (b)(6) 2021, resulting in a total psa value of 0.342 ng/ml.The second sample resulted in a free psa value of 10.28 ng/ml and a total psa value of 0.325 ng/ml when tested on the e 601 analyzer on (b)(6) 2021.This sample was diluted 1:20 and repeated on the e 601 analyzer on (b)(6) 2021, resulting in a total psa value of 0.553 ng/ml.The third sample resulted in a free psa value of 10.76 ng/ml and a total psa value of 0.350 ng/ml when tested on the e 601 analyzer on (b)(6) 2021.The serial number of the e 601 analyzer is (b)(4).The serial number of the e411 analyzer was requested, but not provided.

Manufacturer Narrative

The customer sent the patient sample to the manufacturer for investigation.The investigation reproduced the results obtained by the customer.The investigation showed no evidence of a falsely increased signal for free psa.The investigation did find the presence of an interfering substance(s) that considerably decreased the recovery of total psa.The investigation also suggested the presence of a rare psa isoform that is not completely detected by the total psa assay.These issues are covered in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." a general product problem was not identified.

• Brand Name: ELECSYS FREE PSA TEST SYSTEM
• Type of Device: TEST, PROSTATE SPECIFIC ANTIGEN, FREE, (NONCOMPLEXED)
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12461170
• MDR Text Key: 272948801
• Report Number: 1823260-2021-02680
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 08828601190
• Device Lot Number: 495789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 11/10/2021
• 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