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

Catalog Number 08791732190

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

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

Event Date 09/01/2022

Event Type  malfunction  

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 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 total psa.Refer to the medwatch with a1 patient identifier pt-74182 for information on the free psa results.

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.

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 TOTAL PSA
• Type of Device: 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: 15496388
• MDR Text Key: 301278866
• Report Number: 1823260-2022-02957
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990056
• 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,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 08791732190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 09/20/2022; 11/28/2022
• Supplement Dates FDA Received: 10/14/2022; 12/19/2022
• 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