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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN II SYSTEM

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SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN II SYSTEM Back to Search Results
Catalog Number OVIA11
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/21/2016
Event Type  malfunction  
Manufacturer Narrative
A siemens field service engineer (fse) was dispatched to the customer site on 2016-09-29. Per the fse report, the cause of the discrepant igg results is related to a leak that occurred around the connection of the sample probe tubing. The fse cleaned the connection and replaced the tubing. The instrument is performing within specifications. No further evaluation of the device is required.
 
Event Description
Three discrepant igg patient results were obtained on a bnii instrument. The patient results were reported to the physician. The physician(s) questioned the results. The samples were repeated on an alternate bnii instrument and higher results were obtained. Patient treatment was not altered or prescribed based on the initial igg results. There is no indication of any adverse health consequences due to the initial igg results.
 
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Brand NameBN II SYSTEM
Type of DeviceBN II
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
76 emil von behring strasse
marburg, 35041
GM 35041
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
76 emil von behring strasse
marburg, 35041
GM 35041
Manufacturer Contact
edward szymanski
glasgow business community
po box 6101
newark, DE 19714-6101
3026317672
MDR Report Key6053867
MDR Text Key58614944
Report Number9610806-2016-00029
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K943997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 10/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberOVIA11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2016
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 Reuse

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