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

Catalog Number 08828610190

Device Problem Incorrect Measurement (1383)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

The initial reporter questioned the results for 1 patient sample tested for elecsys free psa (free psa) on two cobas e 801 analytical units.The free psa results were greater than the total psa results.This medwatch will cover free psa.Refer to medwatch with a1 patient identifier (b)(6) for information on the total psa results.On e801 analyzer 1: the free psa result was 1.79 ng/ml.The total psa result was 0.0501 ng/ml.On e801 analyzer 2: the free psa result was 1.68 ng/ml.The total psa result was 0.0552 ng/ml.The sample was manually diluted x3: the free psa result was 1.632 ng/ml.The total psa result was 0.064 ng/ml.On (b)(6) 2023 the sample was tested by competitor method 1: the free psa result was 1.51 ng/ml.The total psa result was 1.66 ng/ml.The sample was tested by competitor method 2: the free psa result was 0.022 ng/ml.The total psa result was 0.190 ng/ml.The questionable results did not match the patient¿s clinical diagnosis and were not reported outside of the laboratory.

Manufacturer Narrative

The serial number for one e801 analyzer was (b)(6).The serial number for the second e801 analyzer was not provided.Competitor method 1 was beckman.Competitor method 2 was abbott.The sample was requested for investigation.

Manufacturer Narrative

The sample was submitted for investigation.The customer's free psa and total psa results were reproduced on a cobas e801: the free psa result was 1.76 ng/ml.The total psa result was 0.049 ng/ml.The sample was further investigated.No interfering factors were identified affecting the free psa reagent.An interferent against a component of the total psa reagent was confirmed.This interference caused the low total psa result.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.For diagnostic results, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." a reagent issue was not found.The investigation did not identify a product problem.

• Brand Name: ELECSYS FREE 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18150401
• MDR Text Key: 328301623
• Report Number: 1823260-2023-03633
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 08828610190
• Device Lot Number: 66931301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic