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

Catalog Number 07027966190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient tested for elecsys free psa (free psa) and elecsys total psa (total psa) on a cobas e 801 module.This medwatch will cover total psa.Refer to medwatch with patient identifier (b)(6) for information on the free psa results.The total psa result was 0.421 ng/ml.The free psa result was 0.672 ng/ml.The customer re-measured the patient sample and obtained the same results.The actual results were not provided.No erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).

Manufacturer Narrative

Expiration date was updated.Qc results were within the acceptable ranges.The patient sample was requested for investigation but was not provided.Since the customer declined to provide additional information or sample material, the investigation could not be completed.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TOTAL PSA IMMUNOASSAY
• 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): 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: 8437078
• MDR Text Key: 139697157
• Report Number: 1823260-2019-01141
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

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: 12/31/2019
• Device Catalogue Number: 07027966190
• Device Lot Number: 340180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 03/05/2019
• Supplement Dates FDA Received: 04/04/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1