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

Catalog Number	08828610190
Medical Device Problem Codes	High Test Results (2457); Mechanical Jam (2983); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys free psa immunoassay result from one patient sample tested on the cobas e 801 analytical unit.The initial result was reported to the clinic.The clinical complaint prompted the rerun of the patient sample.The initial free psa result was 4.57 ng/ml.The first repeat result was 0.530 ng/ml.The second repeat result was 0.518 ng/ml.The third repeat result after high-speed centrifugation was 0.521 ng/ml.The total psa result was 2.9 ng/ml.
Additional Manufacturer Narrative
The customer stated that the sample probe had crystals.The serial number of the customer's cobas e 801 analytical unit is (b)(6) the investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2024.The calibration signals were lower than the expected range.The investigation reviewed the qc data.The qc results using third-party qcs were within specifications before the patient sample was run.The investigation reviewed the alarm trace.There were no issues noted.The investigation reviewed the simple foam detection (sfd) images.There were no issues noted.The investigation determined the event was consistent with the accumulation of crystals on the sample probe.Product labeling states "daily maintenance of the e 801 module - cleaning probes and nozzles of the e 801 module - to ensure that the instrument measures accurately, you must clean the sample probe, reagent probes, the nozzles of the pre-wash area, and the electrochemiluminescent (ecl) sipper nozzle." a general reagent problem was not present because the qc before the event was within specifications.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19335226
• Report Number: 1823260-2024-01476
• Device Sequence Number: 19585643
• Product Code: LTJ
• UDI-Device Identifier: 07613336166628
• UDI-Public: 07613336166628
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 06/18/2024

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: 10/31/2024
• Device Catalogue Number: 08828610190
• Device Lot Number: 730657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian