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

Catalog Number 04491734190

Device Problems High Test Results (2457); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter received questionable high elecsys total psa immunoassay results from a cobas 8000 e 602 module, serial number (b)(4).The customer noticed a shift in their quality control and patient samples after switching to a new tpsa calibrator lot.The customer performed a patient comparison with another laboratory.The other laboratory performed testing on a cobas 6000 analyzer.The customer provided questionable results for one patient.The patient¿s initial tpsa result was 28.73 ng/ml, and the repeat result from another laboratory was 20.87 ng/ml.The initial result was reported outside the laboratory.

Manufacturer Narrative

The customer's calibration and qc were acceptable.A general product problem is excluded.The patient's sample was requested for investigation, but the patient's sample was not available.Based on the available data, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10000242
• MDR Text Key: 222559661
• Report Number: 1823260-2020-01113
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04491734190
• Device Lot Number: 409527
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1