MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FREE PSA; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA

Catalog Number 03289788190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for one patient sample tested with the elecsys total psa immunoassay and the elecsys free psa immunoassay on a cobas 8000 e 602 module and a cobas 6000 e 601 module used for investigation.The free psa values were higher than the total psa values.Incorrect results were reported outside of the laboratory.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 sample was measured on the e 602 analyzer at the customer site, resulting with a total psa value of 0.07 ng/ml and a free psa value of 0.569 ng/ml.The sample was provided for investigation where it was tested on an e 601 analyzer, resulting with a total psa value of 0.040 ng/ml and a free psa value of 0.535 ng/ml.The serial number of the e 601 analyzer used for investigation was (b)(4).Free psa reagent lot number 375053, with an expiration date of april 2020 was used on this analyzer.

Manufacturer Narrative

The sample was requested and made available for investigation.The incorrect result for fpsa/tpsa ratio > 1 was confirmed.The investigation showed no evidence of a falsely increased signal for free psa.The investigation did find the presence of 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.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 product problem was excluded.

• Brand Name: FREE PSA
• Type of Device: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8866476
• MDR Text Key: 153816315
• Report Number: 1823260-2019-02863
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P000027
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03289788190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1