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

Catalog Number 08828601190

Device Problems Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e411 rack serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable free psa elecsys results for one patient from the cobas e411 rack analyzer that were higher than the total psa result for the sample.Sample 1 initial free psa result was 0.058 ng/ml.After replacing the reagent pack, calibration and qc, the repeat result was 0.176 ng/ml.Sample 2 initial free psa result was 0.153 ng/ml.After replacing the reagent pack, calibration and qc, the repeat result was 0.15 ng/ml.The sample was sent to another laboratory and tested using clia methodology.The free psa result was 0.06 ng/ml.The result from the other laboratory was believed to be correct.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

The customer recalibrated the free psa assay and repeated the patient samples.Sample 1 result was 0.020 ng/ml.Sample 2 result was 0.046 ng/ml.The investigation did not identify a product problem and no reagent issue was found.The cause of the event could not be determined as the samples were not available for further investigation.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18095894
• MDR Text Key: 327672223
• Report Number: 1823260-2023-03561
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 12/11/2023

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 08828601190
• Device Lot Number: 669352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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