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

Catalog Number 07027320190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of questionable elecsys free psa immunoassay and elecsys total psa immunoassay results for 1 patient sample tested on a cobas 8000 e801 module.The customer suspects that there is an interference present in the patient sample.This medwatch will cover the free psa data.Please refer to the medwatch with patient identifier (b)(6) for data on the total psa.The initial free psa result was 3.87 ng/ml with repeat results of 3.91 ng/ml and 3.65 ng/ml.The initial total psa result was 3.00 ng/ml with repeat results of 3.05 ng/ml and 2.99 ng/ml.No erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number was (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

The calibration data is within acceptable range for both total psa and free psa.The level 2 qc recovery is within acceptable range for both total psa and free psa.The level 1 qc recovery was not provided.The sample was tested during the investigation and results similar to the customer's were obtained.The investigations suggest the presence of a rare psa isoform that does not react as strongly with the tpsa reagent.The investigation did not identify a product problem.  the cause of the event could not be determined as insufficient sample material was available. .

• 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: 7792760
• MDR Text Key: 117447296
• Report Number: 1823260-2018-02750
• Device Sequence Number: 1
• Product Code: MTG
• UDI-Device Identifier: 04015630940011
• UDI-Public: 4015630940011
• 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: 09/21/2018

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: 06/30/2019
• Device Catalogue Number: 07027320190
• Device Lot Number: 29342701
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 08/01/2018
• Supplement Dates FDA Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1