MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 PSA

Model Number IMMULITE 2000 PSA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant, falsely low psa results on multiple patient samples is unknown.Siemens is investigating the issue.

Event Description

The customer obtained discordant, falsely low prostate specific antigen (psa) results on multiple patient samples on an immulite 2000 xpi instrument, while using kit lot 408.The customer was comparing patient samples values on various lots of reagent and determined that the results obtained on kit lot 408 were lower compared to the results obtained on the same patient samples on kit lot 407 and 410.It is unknown if results were reported to physician(s) from kit lot 407.Results from kit lot 408 were not reported out to physician(s).Results from kit lot 410 were reported out to physician(s).There were no reports of patient intervention or adverse health consequences due to the discordant, falsely low psa results.

Manufacturer Narrative

The initial mdr 2432235-2016-00602 was filed on october 6, 2016.Corrected information (12/02/2016): upon further review, it has been determined that the product is not registered for sale in the u.S and there is no equivalent product for prostate specific antigen catalog # l2kpts2, kit lot 408 available for distribution in united states.No further investigation is needed.

• Brand Name: IMMULITE 2000 PSA
• Type of Device: IMMULITE 2000 PSA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; registration #: 3002806944; glyn rhonwy; llanberis, gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6004345
• MDR Text Key: 56938820
• Report Number: 2432235-2016-00602
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P930027
• 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
• Report Date: 12/02/2016

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 Model Number: IMMULITE 2000 PSA
• Device Catalogue Number: L2KPTS2
• Device Lot Number: 408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1