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 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of erroneous results for 1 patient tested for elecsys total psa immunoassay (total psa) and free psa on a cobas e 411 immunoassay analyzer.The erroneous results were not reported outside of the laboratory.This medwatch will cover free psa.Refer to medwatch with (b)(6) for information on the total psa erroneous results.(b)(6).There was no allegation that an adverse event occurred.The e411 analyzer serial number was not provided.Liquid flow cleaning was last performed on 28-sep-2017.

Manufacturer Narrative

Lot number was updated.The e411 analyzer serial number was (b)(4).Calibration and qc results were acceptable.A specific root cause was not identified.Additional information was requested for investigation but was not provided.Possible root causes may be related to the rare isotype structure of total psa leading to a low total psa result or an unknown interfering component for total psa; however, since the patient sample is not available, this could not be confirmed.

Manufacturer Narrative

Preventive maintenance was performed on the instrument on (b)(6) 2017.A cell blank adjustment was performed as the signals were below expectation.

• 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
• 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: 7006653
• MDR Text Key: 92201029
• Report Number: 1823260-2017-02550
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2017

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: 209877
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 10/17/2017; 10/17/2017
• Supplement Dates FDA Received: 11/17/2017; 12/27/2017
• 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
• Patient Age: 67 YR