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 09/14/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys total psa immunoassay results from 3 patients on a cobas 6000 e601 module.On (b)(6) 2022, patient (b)(6) had a total psa result of 0.027 ng/ml and a free psa result of 0.043 ng/ml.On (b)(6) 2022, patient (b)(6) had a total psa result of 0.006 ng/ml with flag and a free psa result of 0.037 ng/ml.On (b)(6) 2022, patient (b)(6) had a total psa result of 0.017 ng/ml and a free psa result of 0.039 ng/ml.On (b)(6) 2022, patient (b)(6) had another sample collected and the total psa result was 0.024 ng/ml and a free psa result of 0.042 ng/ml.On (b)(6) 2022 at 1:19 p.M., patient (b)(6) had another sample collected.The total psa result was 0.006 ng/ml with flag and the free psa result was 0.038 ng/ml.At 9:20 p.M., the patient had an additional total psa result of 0.006 ng/ml with flag and a free psa result of 0.037 ng/ml.No questionable results were reported outside of the laboratory.The analyzer serial number is (b)(4).This medwatch will cover total psa.Refer to medwatch with patient identifier (b)(6) for information on the free psa results.

Manufacturer Narrative

The investigation found that the customer's calibration signals for free psa calibrator level 1 were below the expected range.It was also found that there were several maintenance activities that were overdue.The investigation is ongoing.

Manufacturer Narrative

The investigation determined that per product labeling, prostatectomized patient measurement of total psa is not covered by the intended use.Per product labeling, "this assay, a quantitative in vitro diagnostic test for total (free + complexed) prostate-specific antigen (tpsa) in human serum and plasma, is indicated for the measurement of total psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer in men aged 50 years or older." additionally, free psa product labeling states, "this assay is indicated for measurement of fpsa in conjunction with the elecsys total psa assay to develop a ratio (% fpsa) of fpsa to tpsa.This ratio is useful when used in conjunction with the elecsys total psa test as an aid in distinguishing prostate cancer from benign prostatic conditions in men age 50 years or older who have a digital rectal examination (dre) that is not suspicious for prostate cancer and an elecsys total psa value in the range 4 ng/ml to 10 ng/m." 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15608448
• MDR Text Key: 306912288
• Report Number: 1823260-2022-03171
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 08791686190
• Device Lot Number: 61494901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male