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

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.

• Brand Name: BN II SYSTEM
• Type of Device: BN 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 Key: 6053867
• MDR Text Key: 58614944
• Report Number: 9610806-2016-00029
• Device Sequence Number: 1
• Product Code: DEW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943997
• 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: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OVIA11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• 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
• Patient Sequence Number: 1