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

Catalog Number 03289788190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they received erroneous results for one patient sample tested for total prostate-specific antigen (tpsa) and free prostate-specific antigen (fpsa) on an e601 analyzer.The fpsa result was greater than the tpsa result.This medwatch will cover fpsa.Please refer to the medwatch with patient identifier (b)(6) for information related to tpsa.The sample resulted as 0.149 ng/ml for tpsa and 2.59 ng/ml for fpsa.The results were reported outside of the laboratory to the patient.The patient was not adversely affected.The e601 analyzer serial number was asked for, but not provided.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations were able to confirm the customer's results.Investigations performed with an antibody that has a different specificity than the one used in the tpsa assay increased tpsa recovery of the sample significantly.Further investigations could not be performed since there was not enough sample remaining.

Manufacturer Narrative

A new sample from the same patient has been provided for investigation.This sample also had erroneous results for fpsa and tpsa.This sample had a fpsa result of 3.180 ng/ml and a tpsa result of 0.220 ng/ml.The erroneous results were not reported outside of the laboratory.The patient was not adversely affected.

Manufacturer Narrative

Investigations of the new patient sample were able to confirm the customer's results.For investigations, a total psa reagent with different analyte specificity was used.Upon use of this reagent, a significant increase in total psa recovery of the sample can be seen.The result of total psa with this reagent is higher than the free psa result.The observed behavior may be explained by the presence of auto-antibodies blocking the epitope on complexed psa or an anti-idiotype antibody which blocks the catcher antibody of the total psa assay.Product labeling indicates that psa isoforms do exist which may be measured differently by different psa tests.

• Brand Name: FREE PSA
• 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: 5584535
• MDR Text Key: 42953785
• Report Number: 1823260-2016-00446
• Device Sequence Number: 1
• Product Code: MTG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 06/22/2016

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: 02/28/2017
• Device Catalogue Number: 03289788190
• Device Lot Number: 188436
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/10/2016; 06/10/2016; 06/22/2016
• 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