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

Catalog Number 08791686190

Device Problem Incorrect Measurement (1383)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

The customer replaced the reagent and has not had any further issues.The customer¿s qc results do not suggest an issue.The pre-analytical information provided does not suggest an issue.No issues were identified during a review of the alarm trace data.The sample was requested for investigation but the sample is no longer available.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant low results for 2 patient samples tested for elecsys total psa (total psa) on a cobas e 411 immunoassay analyzer.Patient 1 total psa result was < 0.006 ng/ml with a data flag.The patient¿s free psa result was 0.664 ng/ml.Patient 2 total psa result was < 0.006 ng/ml with a data flag.The patient¿s free psa result was 0.185 ng/ml no questionable results were reported outside of the laboratory.The e411 analyzer serial number was (b)(4).

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15742559
• MDR Text Key: 307599548
• Report Number: 1823260-2022-03506
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 08791686190
• Device Lot Number: 55609801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• 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