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

Catalog Number 08791732190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable y, elecsys total psa immunoassay results from two patient samples tested on the cobas e 801 analytical unit.The initial results were reported to the physician.The doctor indicated that the results were discrepant with the patients¿ clinical symptoms and their previous results.Patient 1 the initial result was 0.11 ng/ml.The repeat result was 143 ng/ml.Patient 2 the initial result was 0.01 ng/ml.The repeat result was 54.5 ng/ml.

Manufacturer Narrative

The reagent lot number is 652127.The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d1 to d3 and g1-g4 were updated.The field service engineer (fse) checked the analyzer's mechanisms, confirmed the positions, and performed mechanical checks; no issues were noted.He noted that the gear pump pressure was low.He then replaced this part.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TOTAL PSA
• Type of Device: 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 46250-0457
• MDR Report Key: 17468696
• MDR Text Key: 320869604
• Report Number: 1823260-2023-02530
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791732190
• Device Lot Number: 652127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1