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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
Model Number BN II SYSTEM
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2016
Event Type  malfunction  
Manufacturer Narrative
The cause of the imprecise replicate iggc results is unknown. A siemens field service engineer was dispatched to the site and was not able to reproduce the imprecision. Instrument probes were replaced proactively and precision studies were acceptable. The instrument is performing within specifications. No further evaluation of the device is required.
 
Event Description
Imprecise replicate immunoglobulin g (iggc) results were obtained on a patient cerebrospinal fluid (csf) sample on the bnii system. It is unknown if results were reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the imprecise replicate iggc results.
 
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Brand NameBN II SYSTEM
Type of DeviceBN II SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
emil von behring strasse 76
marburg, D-350 41
GM D-35041
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
emil von behring strasse 76
marburg, D-350 41
GM D-35041
Manufacturer Contact
james morgera
glasgow business community
500 gbc drive po box 6101
newark, DE 19714-6101
3026318356
MDR Report Key6312825
MDR Text Key67250141
Report Number9610806-2017-00020
Device Sequence Number1
Product Code DEW
Combination Product (y/n)N
Reporter Country CodeBR
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 02/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBN II SYSTEM
Device Catalogue NumberSMN 10454733
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 Received01/09/2017
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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