MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FREE PSA; TEST, PROSTATE SPECIFIC ANTIGEN, FREE, (NONCOMPLEXED) TO DISTINGUISH PROSTATE

Catalog Number 08828601190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name continued: cancer from benign conditions.The field service engineer (fse) performed various maintenance actions including replacing the measuring cells, photomultiplier tube high voltage adjustment, and blank cell calibration.Calibrations and instrument checks were performed.The gear pump head was confirmed to be within specifications.Qc was acceptable.Calibration was last performed on (b)(6) 2022.Calibration signals were acceptable, however, product labeling states: "calibration frequency: calibration must be performed once per reagent lot using fresh reagent (i.E.Not more than 24 hours since the reagent kit was registered on the analyzer).Renewed calibration is recommended as follows: after 1 month (28 days) when using the same reagent lot after 7 days (when using the same reagent kit on the analyzer) as required: e.G.Quality control findings outside the defined limits." several temperature errors were observed on the alarm trace data.The customer regularly performs daily operator maintenance.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys free psa (free psa) on a cobas 6000 e 601 module.The initial result was 0.012 ng/ml.The repeat result was 3.12 ng/ml.The questionable result was not reported outside of the laboratory.The e601 module serial number was (b)(4).

• Brand Name: ELECSYS FREE PSA
• Type of Device: TEST, PROSTATE SPECIFIC ANTIGEN, FREE, (NONCOMPLEXED) TO DISTINGUISH PROSTATE
• 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: 16439261
• MDR Text Key: 310336045
• Report Number: 1823260-2023-00579
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/24/2023

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: 06/30/2023
• Device Catalogue Number: 08828601190
• Device Lot Number: 61761502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/24/2023
• 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