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

Catalog Number 08791686190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's calibration and qc data were requested but not provided.The patient's sample was requested for an investigation, but the patient's sample was not available.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable elecsys total psa and elecsys free psa immunoassay results for one patient tested on a cobas e411 disk serial number (b)(4).The patient¿s total psa and free psa results were not reported outside the laboratory.The patient¿s total psa result was 0.006 ng/ml, and the patient¿s free psa result was 0.087 ng/ml.The total psa and free psa reagent lot numbers and expiration dates were requested but not provided.This medwatch is for total psa.Refer to the medwatch with patient identifier (b)(6) for the free 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10810427
• MDR Text Key: 216171581
• Report Number: 1823260-2020-02823
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08791686190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2020
• 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