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

Catalog Number	08828610190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem 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 e 801 analytical unit.The free psa values were greater than the total psa values.The questionable results were reported outside of the laboratory.This medwatch will apply to the free psa assay.Please refer to the medwatch with patient identifier.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 2.88 ng/ml.The first sample initially resulted in a total psa value of 0.180 ng/ml.A second sample of the patient was tested on an unknown date: the second sample initially resulted in a free psa value of 2.79 ng/ml and repeated in a different laboratory on a cobas pure analyzer as 2.74 ng/ml.The second sample initially resulted in a total psa value of 0.174 ng/ml and repeated in a different laboratory on a cobas pure analyzer as 0.19 ng/ml.The patient went to another laboratory and received a free psa value of 0.068 ng/ml and a total psa value of 0.415 ng/ml.The method used and the date of measurement is unknown.The serial number of the e801 analyzer is (b)(4).
Additional Manufacturer Narrative
The last preventive maintenance was performed on 27-oct-2022 including a measuring cell change.The customer does not run quality controls daily.
Additional Manufacturer Narrative
Calibration signals were within the expected range.No quality control results for level 1 were provided.Quality control results of level 2 were acceptable for free psa.Upon review of the alarm trace, no relevant alarms were observed.The customer stores calibrators and controls in the freezer without temperature control.The customer thaws the aliquots, runs the quality control or calibrators, and freeze them again.The samples were requested but were not available for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with an interference and/or a seldom psa isoform present in the sample that leads to the free psa values being greater than the total psa values.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies to analytes specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".

• Brand Name: ELECSYS FREE PSA
• Common Device Name: 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16549458
• Report Number: 1823260-2023-00822
• Device Sequence Number: 17653098
• Product Code: LTJ
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: P000027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 08828610190
• Device Lot Number: 61763202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown