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

Catalog Number 08791732190

Device Problem Low Test Results (2458)

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

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e 801 analyzer was requested, but not provided.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with elecsys total psa on a cobas e 801 module.The clinician suspected that total psa patient results were incorrectly low.The customer noted that the ion blower on the analyzer lacked power, so they disposed of the reagent that was in use and started using the standby total psa reagent pack.The customer repeated 11 patient samples with the standby pack and of these, two had discrepant results.The first sample initially resulted in a total psa value of 4.88 ng/ml and it repeated as 0.02 ng/ml.The second sample initially resulted in a total psa value of 346.0 ng/ml and it repeated as 3.49 ng/ml.

Manufacturer Narrative

The questionable results were not reported outside of the laboratory to the patients.For sample 1, the initial total psa value was 0.02 ng/ml and the repeat value was 4.88 ng/ml.For sample 2, the initial total psa value was 3.49 ng/ml and the repeat value was 346.0 ng/ml.The customer stated there was absence of power to the ion blower on the analyzer.A field service engineer ran performance testing and precision studies.No problems were observed.The investigation is ongoing.

Manufacturer Narrative

For the last calibration performed on (b)(6) 2023, the calibration signals were lower than expected.Quality controls recovered well within range.A general reagent related issue or single reagent pack failure can be excluded as a root cause as controls were acceptable on the day of the event.No further issues occurred after the replacement of the reagent pack.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TOTAL PSA
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18012112
• MDR Text Key: 326622739
• Report Number: 1823260-2023-03435
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 07613336165980
• UDI-Public: 07613336165980
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791732190
• Device Lot Number: 652127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1