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

Catalog Number ASKU

Device Problem Incorrect Measurement (1383)

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

Event Date 06/24/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys free psa immunoassay results for 1 patient sample on a cobas pro module.The initial free psa result was 2.27 ng/ml and the initial total psa result was 0.129 ng/ml.The repeat free psa result was 2.16 ng/ml and the repeat total psa result was 0.123 ng/ml.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.H3 other text : na.

Manufacturer Narrative

The sample was requested for investigation but was not provided.No further data was provided for the investigation.Based on the information provided, 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) TO DISTINGUISH PROSTATE CA
• 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: 17356900
• MDR Text Key: 319512658
• Report Number: 1823260-2023-02361
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 09/01/2023

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 09/01/2023
• 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
• Treatment: METFORMIN; TRAMADOL
• Patient Sex: Male