MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FREE PSA; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number	08828610190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information for the investigation was requested but was not provided.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter received questionable elecsys total psa immunoassay and elecsys free psa immunoassay results from 1 patient on a roche immunoassay analyzer.The initial total psa result was 9.78 ng/ml and the first repeat result was 9.73 ng/ml.The initial free psa result was 12.9 ng/ml and the first repeat result was 13.5 ng/ml.A dilution was performed and the second repeat total psa result was 9.56 ng/ml and the second repeat free psa result was 13.6 ng/ml.It is unclear if these results were from a separate sample.It is unknown if any results were reported outside of the laboratory.The analyzer model and serial number were requested but not provided.This medwatch will cover free psa.Refer to the medwatch with patient identifier (b)(6)for information on the total psa results.
Additional Manufacturer Narrative
The sample was submitted for investigation.The total psa result was 5.88 ng/ml and the free psa result was 5.58 ng/ml.Gel filtration testing was also performed and the results showed that the amount of free psa in the patient sample was higher than the amount of total psa.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation found that there were no abnormal amounts of igg or igm detected in the sample.The investigation determined the issue is consistent with a rare psa-isoform that cannot be completely detected by the usage of standard total psa elecsys assay.The impact of the rare psa isoform on the elecsys results is also mentioned in the method sheet for total psa.Product labeling states, "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." there is no evidence that the elecsys free psa and total psa assays are disturbed by endogenous interfering substances.The original free psa measured value is considered to be correct.The investigation did not identify a product problem.Based on the available data, a general reagent issue could be excluded.

• Brand Name: ELECSYS FREE PSA
• Common Device Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15496262
• Report Number: 1823260-2022-02956
• Device Sequence Number: 5171690
• Product Code: LTJ
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 08828610190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 11/28/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/14/2022; 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown