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

Catalog Number 08791686190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

The e601 module serial number was (b)(6).

Event Description

The initial reporter questioned a high result not corresponding to the clinical picture for 1 patient sample tested for elecsys total psa (total psa) on a cobas 6000 e 601 module.The initial result was 0.036 ug/l.An aliquot of the sample was repeated twice in a hitachi cup with results of 0.006 ug/l.The customer is questioning the high result as the total psa result is relevant for follow up testing for this patient who underwent a prostatectomy.

Manufacturer Narrative

Calibration data was provided for the time period of (b)(6) 2023 through (b)(6) 2023.The calibration signals for the date of the event could not be determined as the calibration data did not contain specific dates.Qc data was provided for (b)(6) 2023.The qc results were mostly on target with some results between the target and [-] 2 standard deviations (sd).No issues were identified during a review of the preanalytical data.Several "abnormal sample aspiration" alarms were observed on the alarm trace data.One of these alarms occurred on the day of the event; this alarm suggests sample pipetting issues.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
• Type of Device: TOTAL PROSTATE SPECIFIC ANTIGEN
• 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: 17694938
• MDR Text Key: 322811003
• Report Number: 1823260-2023-02903
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): Y
• Reporter Country Code: BE
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791686190
• Device Lot Number: 70823701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• 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