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

Catalog Number 08828601190

Device Problem Incorrect Measurement (1383)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name continued: cancer from benign conditions calibrations performed on (b)(6) 2023 had signals below the expected range.Quality controls were acceptable.Instrument performance testing was acceptable.The investigation is ongoing.

Event Description

The initial reporter stated they received questionable results for one patient tested with the elecsys free psa and the elecsys total psa assay on a cobas e411 analyzer.The free psa values were greater than the total psa values.The questionable results were not reported outside of the laboratory.This medwatch will apply to the free psa assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the total psa assay.A first sample of the patient was tested on (b)(6) 2023: the first sample initially resulted in a free psa value of 1.46 ng/ml.The first sample initially resulted in a total psa value of 0.066 ng/ml.A second sample of the patient was tested on (b)(6) 2023: the second sample initially resulted in a free psa value of 1.58 ng/ml.The second sample initially resulted in a total psa value of 0.061 ng/ml.A third sample of the patient was tested on (b)(6) 2023 in a different laboratory using the siemens method: the third sample initially resulted in a free psa value of 0.03 ng/ml.The third sample initially resulted in a total psa value of 1.21 ng/ml.The results obtained with the siemens method are considered correct.The serial number of the e411 analyzer is (b)(6).

Manufacturer Narrative

The patient sample was requested for investigation but could not be provided.The investigation could not identify a product problem.The 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
• 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: 16919287
• MDR Text Key: 315098274
• Report Number: 1823260-2023-01615
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• 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: 07/17/2023

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: 06/30/2023
• Device Catalogue Number: 08828601190
• Device Lot Number: 617615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/17/2023
• 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: 54 YR
• Patient Sex: Male