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

Catalog Number	07027320190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2018-02750
• Device Sequence Number: 13732343
• Product Code: MTG
• UDI-Device Identifier: 04015630940011
• UDI-Public: 4015630940011
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P000027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 07027320190
• Device Lot Number: 29342701
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1