MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number 08791686160

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 12/18/2023

Event Type  malfunction  

Event Description

We received an allegation about discrepant results for 1 patient's plasma sample tested with elecsys total psa (tpsa) assay on a cobas 6000 e601 immunoassay analyzer.Initial result: >100 ng/ml (accompanied with a data flag).This result was not reported outside the laboratory.An auto-dilution 1:50 was performed and resulted in a repeat value of 0.7 ng/ml that was reported outside the laboratory.The physician questioned the result as it did not match the patient's diagnosis and his clinical history.The customer was not sure which result was correct and, therefore, they ran the sample for the 3rd time.The 2nd repeat result was not provided.

Manufacturer Narrative

The tpsa reagent expiration date was not provided.The cobas e601 module serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

Calibration, qc, and alarm trace data were requested but not provided.The field service engineer (fse) verified all probe adjustments, replaced the pinch tubing, and verified the module pressure.He ran an assay performance check and it was successful.The fse did a performance testing and the instrument was performing within specifications.Qc was performed and it was successful.The service actions done by the fse resolved the issue.No further issues were reported afterward.

• Brand Name: ELECSYS TOTAL PSA
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18477184
• MDR Text Key: 332455031
• Report Number: 1823260-2024-00103
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 07613336165997
• UDI-Public: 07613336165997
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791686160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• 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: 68 YR
• Patient Sex: Male