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

Catalog Number	08791686160
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys total psa (total psa) result from one patient sample tested on the cobas e411 rack.The initial result was reported to the physician.The physician questioned the result as it was not reflective of the patient's condition.The initial result from the analyzer was 0.06 ng/ml.The first repeat result from the analyzer was 4.2 ng/ml.This repeat result was deemed correct.  the second repeat result from their other e 411 was 4.5 ng/ml.
Additional Manufacturer Narrative
The reagent lot number is 708242.The expiration date was requested but not provided.The field service engineer inspected the analyzer and was not able to establish a cause for the event.He then verified the proper mechanical alignments and performed service testing with successful results.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on 03-nov-2023.The calibration signal 1 was within specifications; calibration signal 2 was slightly lower than expected.The investigation reviewed the qc recovery; the recovery was within -2 standard deviations (sd); the results were within specifications.There is no indication of a performance issue with the reagent or analyzer.The investigation reviewed the alarm trace; the trace had no conspicuous alarms but the cumulative alarm trace had an "assay reagent vol.Inadequate" alarm.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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 46250-0457
• MDR Report Key: 18261803
• Report Number: 1823260-2023-03840
• Device Sequence Number: 19805861
• Product Code: MTF
• UDI-Device Identifier: 07613336165997
• UDI-Public: 07613336165997
• Combination Product (Y/N): Y
• Initial Reporter State: VI
• 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): 01/02/2024
• 2 Devices were Involved in the Event: 1 2

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: 708242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APRESOLINE 50 MG TID.; CIALIS 5 MG 1/DAY.; JANUMET 50-100 MG PER TAB BID.; OLMESARTAN - AMLODIPINE 40/10/25 MG TABLET 1/DAY.; SYNTHROID 175 MCG 1/ DAY.
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 109 KG