MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA); TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number 04641655190

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Upon troubleshooting the issue, it was determined that the samples were run using a free psa calibration that had low signals for one calibrator level compared to previous calibrations.On 04-feb-2021, the free psa assay was recalibrated and the signal level changed back to previous levels.The second patient sample was repeated on (b)(6) 2021 on the e411 analyzer, resulting with a total psa value of 0.002 ng/ml accompanied by a data flag and a free psa value of < 0.010 ng/ml accompanied by a data flag.This event occurred in (b)(6).Unique identifier (udi): (b)(4).

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with the elecsys total psa immunoassay and the elecsys free psa immunoassay on a cobas e 411 immunoassay analyzer.No incorrect results were reported outside of the laboratory for the first two samples.This medwatch will cover the total psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to free psa.The first patient sample resulted with a total psa value of 0.005 ng/ml and a free psa value of 0.130 ng/ml on the e411 analyzer.The sample was sent to another laboratory for testing using a chemiluminescence immunoassay manufactured by siemens, resulting with a total psa value of 0.02 ng/ml and a free psa value of 0.01 ng/ml (percentage of free psa/psa total = 50%).The siemens results were considered correct and released to the physician.The second patient sample resulted with a total psa value of < 0.002 ng/ml accompanied by a data flag and a free psa value of 0.129 ng/ml on the e411 analyzer on (b)(6) 2021.The sample was sent to another laboratory for testing using a chemiluminescence immunoassay manufactured by siemens, resulting with a total psa value of 0.02 ng/ml and a free psa value of 0.01 ng/ml (percentage of free psa/psa total = 50%).The siemens results were considered correct and released to the physician.The third patient sample resulted with a total psa value of < 0.002 ng/ml accompanied by a data flag and a free psa value of 0.128 ng/ml on the e411 analyzer on (b)(6) 2021.These values were released outside of the laboratory to the physician.The serial number of the e411 analyzer is (b)(4).

Manufacturer Narrative

Control results were within expectations, but the customer did not measure both levels of control every day.Upon review of the alarm trace, no relevant alarms were observed.The investigation determined the issue was resolved by recalibration of the free psa assay.

• Brand Name: TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)
• 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: 11378911
• MDR Text Key: 238619732
• Report Number: 1823260-2021-00579
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04641655190
• Device Lot Number: 470243
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAPTOPRIL (PATIENT 1); GLIBENCLAMIDA (PATIENT 1); METFORMINA (PATIENT 1)
• Patient Age: 60 YR