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	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for samples from two patients tested with the elecsys free psa and the elecsys total psa assay on a cobas e 801 module.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 a1.Patient identifier (b)(6) for information related to the total psa assay.Patient 1: on (b)(6) 2023, the sample initially resulted in a free psa value of 0.0138 ng/ml and repeated as 0.0138 ng/ml.On (b)(6) 2023, the sample initially resulted in a total psa value of < 0.006 ng/ml, accompanied by a data flag.Patient 2: on (b)(6) 2023, the sample initially resulted in a free psa value of 0.0114 ng/ml.On (b)(6) 2023, the sample was repeated, resulting in a free psa value of 0.0105 ng/ml.On (b)(6) 2023, the sample initially resulted in a total psa value of < 0.006 ng/ml, accompanied by a data flag.On (b)(6) 2023, the sample initially resulted in a total psa value of < 0.006 ng/ml, accompanied by a data flag.The serial number of the cobas e 801 module is (b)(6).
Additional Manufacturer Narrative
The field service engineer found an issue with the reagent probe and crystallization in the pre-wash rinse station.The rinse stations, sample and reagent probes, and pre-wash flow paths were cleaned.Measuring cell preparation was performed.These maintenance issues were not related to the reported event.The patient samples were requested for investigation but could not be provided.Based on the information provided, a general reagent-related issue can be excluded.The reagent performs within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 17309611
• Report Number: 1823260-2023-02235
• Device Sequence Number: 12578065
• Product Code: LTJ
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 08828610190
• Device Lot Number: 66931301
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/07/2023
• 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