MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA IMMUNOASSAY; TOTAL PROSTATE SPECIFIC ANTIGEN TEST

Catalog Number	08791716160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable total psa elecsys results from the cobas 8000 - cobas e 602 module.Patient 1 initial result was <0.010 ng/ml and repeat the result was approximately 9 ng/ml.Patient 2 initial result was <0.010 ng/ml and the repeat result was approximately 4 ng/ml.The questionable results were not reported outside of the laboratory.The repeat result was believed correct.
Additional Manufacturer Narrative
The cobas 8000 - cobas e 602 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field d4 lot no and d4 expiration date were updated.For patient 1, the initial result was actually 0.016 ng/ml with a data flag.For patient 2, the initial result was actually 0.016 ng/ml with a data flag and the repeat result was actually 4.04 ng/ml.The field service engineer adjusted the probe to ensure the probe was centered over the sample tube.The investigation determined the issue was consistent with an improper sample probe adjustment for the new tube type used by the customer.The issue was resolved by the sample probe adjustment for the new sample tube type.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• Common Device Name: TOTAL PROSTATE SPECIFIC ANTIGEN TEST
• 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: 18904165
• Report Number: 1823260-2024-00761
• Device Sequence Number: 12742536
• Product Code: MTF
• UDI-Device Identifier: 07613336166000
• UDI-Public: 07613336166000
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 04/15/2024

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: 07/31/2024
• Device Catalogue Number: 08791716160
• Device Lot Number: 70823100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/15/2024
• 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 Sex: Unknown