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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer complained of discrepant results for 1 patient sample tested for elecsys total psa immunoassay (total psa) and elecsys free psa immunoassay (free psa) on a cobas 6000 e 601 module.This medwatch will cover free psa.Refer to medwatch with (b)(6) for information on the total psa erroneous results.(b)(6).No incorrect results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e601 module serial number used for the initial results was (b)(4).The serial number for the e601 module used for repeat testing was not provided.

Manufacturer Narrative

An assay related issue was not detected.The patient sample was submitted for investigation.The investigation was able to reproduce the customer's allegation.The low total psa results were caused by an endogenous interfering substance affecting the epitope or the paratope of the anti-psa anitbody.

• Brand Name: ELECSYS FREE PSA IMMUNOASSAY
• Type of Device: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7331221
• MDR Text Key: 102450164
• Report Number: 1823260-2018-00774
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 02/22/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1