MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY V3; FREE PROSTATE-SPECIFIC ANTIGEN

Catalog Number 08828601160

Device Problem Incorrect Measurement (1383)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

The patient's sample was requested but not available for an investigation.The investigation reviewed the qc results and no abnormalities were found.The investigation reviewed the system's alarm trace and found an abnormal sample aspiration alarm.Per product labeling, "the elecsys free psa immunoassay should be used only with the elecsys total psa immunoassay to calculate the ratio (% fpsa) of free psa (fpsa) to total psa (tpsa).Use of another manufacturer¿s total psa assay may result in an inappropriate population of patients selected for fpsa testing; and significantly different fpsa to tpsa ratios, cutoffs and prostate cancer probabilities than represented in the "expected values" section of this method sheet.Ratios must be calculated using tpsa and fpsa results both obtained on the same elecsys platform, i.E.Both obtained on either the cobas e 411, cobas e 601 or cobas e 602 immunoassay analyzer.The measured fpsa value of a patient¿s sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the fpsa assay method used.Free psa values determined on patient samples by differing testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations." based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable elecsys total psa and elecsys free psa immunoassay results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).On (b)(6) 2022, the elecsys psa results were not reported outside the laboratory.The customer performed repeat testing with the sample on the same e 601 module.On (b)(6) 2022, a new sample was collected and tested on the e 601 module.On (b)(6) 2022, the customer sent the sample to a different laboratory and the sample was tested with chemiluminescence methodology.On (b)(6) 2022, the patient's initial results on the e 601 module were total psa 0.80 ng/ml and free psa 1.33 ng/ml.The patient's repeat results on the e 601 module were total psa 0.81 ng/ml and free psa 1.39 ng/ml.On (b)(6) 2022, the patient's new sample was tested on the e 601 module and the results were total psa 0.084 ng/ml and free psa 1.30 ng/ml.On (b)(6) 2022, the patient's results with the chemiluminescence methodology were total psa 0.93 ng/ml and free psa 0.02 ng/ml.The elecsys total psa reagent lot number was 556098 with an expiration date of 30-nov-2022.The elecsys free psa reagent lot number was 546160 with an expiration date of 30-sep-2022.This medwatch is for free psa.Refer to the medwatch with patient identifier (b)(6) for the total psa assay.

• Brand Name: ELECSYS FREE PSA IMMUNOASSAY V3
• Type of Device: FREE 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: 15006114
• MDR Text Key: 304607240
• Report Number: 1823260-2022-02082
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336166673
• UDI-Public: 07613336166673
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P000027
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 08828601160
• Device Lot Number: 546160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/13/2022
• 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: 75 YR