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

Catalog Number 04491734160

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

The alarm trace contained many alarms indicated poor sample quality.The required sample rack adapters were not being used.The field service representative checked fluidic, mechanical, reagent and sampling systems.The sample liquid level detection (lld) voltage was out of specification and was adjusted.The customer ran successful qc.Sample from the patient was requested.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys total psa immunoassay results for multiple patient samples from several cobas 8000 cobas e 602 modules.Of the data provided, only the results for one sample were a reportable malfunction.The initial result from serial number (b)(4) was 0.044 ng/ml with a data flag.The repeat result from serial number (b)(4) was 9.21 ng/ml.On (b)(6) 2019, the result from serial number (b)(4) was 9.00 ng/ml.The result of 0.044 was reported outside of the laboratory and a corrected report was sent.

Manufacturer Narrative

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: 8840382
• MDR Text Key: 152688575
• Report Number: 1823260-2019-02764
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 04491734160
• Device Lot Number: 366540
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR