MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOTAL PSA; TOTAL PROSTATE SPECIFIC ANTIGEN

Catalog Number 08791686190

Device Problem Incorrect Measurement (1383)

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

Event Date 08/26/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys total psa immunoassay and elecsys free psa immunoassay results from multiple patients on a cobas 6000 e601 module.The customer alleged that they had multiple patient results where the free psa result was higher than the total psa result.The specific results were requested but not provided.It is unknown if any questionable results were reported outside of the laboratory.The free psa reagent lot is 617615 and the expiration date is 30-jun-2022.The analyzer serial number is (b)(4).

Manufacturer Narrative

On (b)(6) 2022, total psa calibration signals were high for cal level 1.On (b)(6) 2022, total psa was recalibrated with a new calibrator successfully.Qc was performed and was acceptable.The issue was resolved by recalibrating the total psa assay.

• Brand Name: ELECSYS TOTAL PSA
• Type of Device: TOTAL 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: 15447129
• MDR Text Key: 305998426
• Report Number: 1823260-2022-02868
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• 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: 08791686190
• Device Lot Number: 61494901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• 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