MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA ELECSYS E2G 300 V2; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number 08791732190

Device Problem High Test Results (2457)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

The patient's sample was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter stated they received questionable results for two samples collected from the same patient and tested with the elecsys total psa ver.2 immunoassay on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.The first sample collected from the patient resulted in a total psa value of 13.1 ug/l when tested on the e 801 analyzer.The sample was sent to other laboratories for repeat testing on a siemens attelica im1300 and a beckman coulter unicel dx1800.The result from the siemens analyzer was 0.2 ug/l and the result from the beckman analyzer was 0.095 ug/l.The second sample collected from the patient resulted in a total psa value of 11.1 ug/l when tested on the e 801 analyzer on (b)(6) 2021.The sample was sent to other laboratories for repeat testing on a siemens attelica im1300 and a beckman coulter unicel dx1800.The result from the siemens analyzer was 0.15 ug/l and the result from the beckman analyzer was 0.115 ug/l.The patient samples were checked for heterophile antibody interference with the roche and siemens methods and there were no differences in respective values.The serial number of the e 801 analyzer was requested, but not provided.

Manufacturer Narrative

A third sample collected from the same patient also had a discrepancy in psa results.This sample initially resulted in a psa value of 16.30 ug/l when tested on the e 801 analyzer on (b)(6)-2021.The sample was repeated on an advia centaur xpt analyzer, resulting in a psa value of 0.27 ug/l.Medwatch field b3.Has been updated.

Manufacturer Narrative

A sample from the patient, dated (b)(6)2021 was provided for investigation.Upon initial investigation of the sample, it was tested with the total psa reagent on an e801 resulting in a value of 7.89 ng/ml and on a cobas e 411 immunoassay analyzer resulting in a value of 8.50 ng/ml.The investigation is ongoing.

Manufacturer Narrative

Investigation of the submitted patient sample determined there was an interfering substance in the sample.These interference are documented in product labeling for the assay: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.

• Brand Name: TOTAL PSA ELECSYS E2G 300 V2
• Type of Device: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12478058
• MDR Text Key: 271676397
• Report Number: 1823260-2021-02701
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 08791732190
• Device Lot Number: 492361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• 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