MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number	08791686160
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results for 3 patients tested for elecsys total psa (total psa) that did not correspond to their clinical history on a cobas e 411 immunoassay analyzer.On (b)(6) 2023 patient 1 result was 1.3 ng/ml.On (b)(6) 2023 a new sample was obtained and the result was 229 ng/ml.On (b)(6) 2023 patient 2 result was less than 0.01 ng/ml.On (b)(6) 2023 a new sample was obtained and the result was 4.69 ng/ml.On (b)(6) 2023 patient 3 result was 0.02 ng/ml.On (b)(6) 2023 a new sample was obtained and the result was 32.2 ng/ml.
Additional Manufacturer Narrative
The e411 analyzer serial number was (b)(4).
Additional Manufacturer Narrative
The medical device problem code was updated.The customer replaced the reagent pack and made a new calibrator.Calibration and qc passed.The field service engineer (fse) visited the customer site and confirmed the issue was resolved after the customer replaced the reagent pack and made a new calibrator.

• Brand Name: ELECSYS TOTAL PSA
• Common Device Name: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• 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: 17641224
• Report Number: 1823260-2023-02794
• Device Sequence Number: 20817393
• Product Code: MTF
• UDI-Device Identifier: 07613336165997
• UDI-Public: 07613336165997
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P990056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 08791686160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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