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

Model Number BN II SYSTEM

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely low albu result was obtained on a patient urine sample on the bn ii system.The customer indicated that there were no system errors at the time of the event.Additionally, quality controls were within expected ranges at the time of the event.The customer reported that the results obtained on the other urine samples tested for albumin, during the time period that the affected sample was initially tested, recovered acceptably.The customer deleted the instrument files required to investigate the cause of the discordant, falsely low albu result.The cause of the discordant result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely low albumin (albu) result was obtained on a patient urine sample on a bn ii system.The discordant result not reported to the physician(s).The sample was repeated on the same system, resulting higher.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low albu result.

• Brand Name: BN II SYSTEM
• Type of Device: BN II SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; am kronberger hang 3; registration number:3003601075; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7919082
• MDR Text Key: 122463423
• Report Number: 9610806-2018-00100
• Device Sequence Number: 0
• Product Code: CIX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BN II SYSTEM
• Device Catalogue Number: 10462274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 31 YR