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

Catalog Number 08828601190

Device Problem Incorrect Measurement (1383)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys free psa immunoassay and elecsys total psa immunoassay results for 1 patient sample on a cobas e 801 analytical unit.The initial free psa result was 4.74 ng/ml.The initial total psa result was 0.329 ng/ml.The results were reported outside of the laboratory.The sample was diluted by a factor of 1:5 and repeated.The diluted free psa result was 4.70 ng/ml and the diluted total psa result was 0.389 ng/ml.The sample was then tested on a cobas e602 analyzer.The first free psa result was 5.7 ng/ml, the repeat free psa result was 5.85 ng/ml, and the total psa result was 0.422 ng/ml.The sample was also tested on an abbott analyzer.The initial free psa result was 0.068 ng/ml and the repeat result was 0.073 ng/ml.The initial total psa result was 1.598 ng/ml and the repeat result was 1.531 ng/ml.The cobas e 801 analyzer serial number is (b)(4).This medwatch will cover free psa.Refer to medwatch with patient identifier (b)(6) for information on the total psa results.

Manufacturer Narrative

Calibration was last performed on (b)(6) 2022.Qc results were acceptable.The sample was not available for investigation.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS FREE PSA
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15926019
• MDR Text Key: 308028652
• Report Number: 1823260-2022-03903
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• 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: 12/27/2022

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 08828601190
• Device Lot Number: 61763201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/27/2022
• 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