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

Catalog Number 03289788160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of questionable results for 1 patient sample tested for elecsys free psa immunoassay elecsys (psa free) total psa immunoassay (psa total) on a cobas 8000 e 602 module.(b)(4).The initial psa free result was 0.3 ng/ml which was greater than the initial psa total result of 0.06 ng/ml.There were no flags present on the initial results.The customer repeated the sample for both psa free and psa total on both the same analyzer and on another analyzer, running the sample both undiluted and diluted, and all the results obtained matched (no specific values provided).The erroneous results were reported outside of the laboratory.There was no adverse event.The customer stated that all qc results have been within range.The field engineering specialist was not able to find a cause.He checked the instrument and found no issues.He ran performance and precision testing which had acceptable results.Psa total qc testing was performed which passed.(b)(6).

Manufacturer Narrative

The initial testing was done on aliquots processed by a modular pre-analytics system.All repeat testing was done by manually by loading the primary tube onto the analyzer.Rack adapters were used.

Manufacturer Narrative

The patient sample was provided for investigation.The customer's results were confirmed during the investigation.A substance in the patient's sample caused an interference.This limitation is covered in product labeling.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the customer stated that there have been no further issues.

• 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: 7133310
• MDR Text Key: 95903516
• Report Number: 1823260-2017-03058
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2018

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 03289788160
• Device Lot Number: 24314201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 12/11/2017
• Supplement Dates FDA Received: 01/05/2018; 02/12/2018
• 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: 63 YR