MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW STRATUS CS

Catalog Number 10444834

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens current product support (cps) team investigated the issue.Investigation summary: internal testing did not find that heterophilic antibody interference caused the > 20,000 pg/ml pbnp results for this patient sample.Treatment with the heterophilic antibody blocker did not reduce the clinical result; after treatment with the blocking agent the pbnp results remained elevated and constant.Because another method returned a result of 1,683 pg/ml, this suggests there is some kind of antibody interference occurring with this patient sample but it is not heterophilic interference.This interference would create the > 20,000 pg/ml results.

Event Description

A customer from (b)(6) reported different samples from one patient that returned a pbnp value of > 20,000 pg/ml even after several dilution attempts.The three dilutions that were initially attempted were a 1:3, 1:5, and 1:10 using normal saline at a 0.9% concentration (recommended in ifu: 0.85%).Customer then did a 1:50 dilution and got a result of 213,538.8 pg/ml.Another sample was taken from the patient in an edta tube and it was sent to a reference lab for testing on another method and this method returned a result of 1,683.0 pg/ml.The patient sample in question was tested with testpak lot 215194002 on the stratus cs instrument sn(b)(4).All qc data and calibration data for the instrument and the pbnp lot215194002 was acceptable.There was no report of injury due to this event.

• Brand Name: STRATUS CS
• Type of Device: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5173582
• MDR Text Key: 29217455
• Report Number: 1217157-2015-00148
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2015

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: Other Health Care Professional
• Device Catalogue Number: 10444834
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2015
• Initial Date FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1