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 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.The customer treated the patient sample with a heterophilic blocking tube and tested it on the immulite 2000 xpi instrument, using reagent kit lot 410 and the results were lower.This indicated that heterophilic antibodies were elevating the result of this sample with the immulite 2000 xpi psa assay.As stated in the immulite 2000 psa instructions for use (ifu), "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays.Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result.These reagents have been formulated to minimize the risk of interference; however, potential interactions between rare sera and test components can occur.For diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings." a siemens headquarters support center specialist reviewed the sample data and determined that immulite 2000 psa reagent kit lot 410 is performing as intended.No further evaluation of device is required.

Event Description

Discordant, falsely elevated prostate specific antigen (psa) results were obtained on one patient on an immulite 2000 xpi instrument, when using reagent kit lot 410.The sample was initially tested on an alternate platform, where the result was lower.The sample was then re-run after treatment with heterophilic blocking tube on both the immulite 2000 xpi instrument and on the alternate platform.The results obtained after treatment were lower on the immulite 2000 xpi platform.The discordant results were not reported to the physician(s).The correct results obtained on the alternate platform were reported to the physician(s).There are no known reports of patient intervention or adverse health consequence as a result of discordant, falsely elevated psa results.

• Brand Name: IMMULITE 2000 PSA
• Type of Device: IMMULITE 2000 PSA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; uk 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: 6322898
• MDR Text Key: 67326140
• Report Number: 2432235-2017-00111
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• 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 Lot Number: 410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• 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
• Patient Age: 76 YR