MAUDE Adverse Event Report: IMMULITE 2000 PSA

Catalog Number	L2KPTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens customer care center (ccc) specialist offered to dispatch service to the customer site, but the customer declined.The customer informed siemens that there were no system performance errors or other errors related to reagents and components.The customer reviewed the results of 17 other patient samples that were run on the same instrument on (b)(6) 2018 and the results were acceptable.The customer could not confirm if the sample that was discordant was mixed well before being initially tested and the low result could have been due to sample handling issues.As there were no other errors identified on the system, the falsely low psa result may have been due to improper mixing of the sample.The system is performing within specifications.
Event or Problem Description
A discordant, falsely low prostate specific antigen (psa) result was obtained on one patient sample on an immulite 2000 instrument.The discordant result was reported to the physician(s) and was questioned.The same sample was repeated on the same instrument, resulting higher.A new blood draw was taken from the same patient on a different date and was run on the day it was drawn on the same immulite 2000 instrument as the previous sample.The results of the repeat of the initial sample and the new blood draw matched.There are no known reports of patient intervention or adverse health consequences to the patient due to the discordant falsely low psa result.

• Brand Name: IMMULITE 2000 PSA
• Common Device Name: IMMULITE 2000 PSA
• MDR Report Key: 7481067
• Report Number: 2432235-2018-00191
• Device Sequence Number: 13492651
• Product Code: MTF
• UDI-Device Identifier: 00630414982212
• UDI-Public: 00630414982212
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P930027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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 Catalogue Number: L2KPTS
• Device Lot Number: D129
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/02/2018
• Patient Sequence Number: 1