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

Model Number	BN PROSPEC SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely low albumin result was obtained on a patient cerebrospinal fluid (csf) sample on a bn prospec system using n antiserum to human albumin reagent.The discordant result was not reported to the physician(s), as it did not match the patient's total protein result.The same sample was repeated twice for albumin csf, recovering higher.The repeat results were reported, as the correct results, to the physician(s).Two days later, the same sample was repeated again for albumin csf, recovering higher and confirming the repeat results from two days prior.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low albumin csf result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2020-00059 on 13-nov-2020.Additional information (17-nov-2020): section b7 of the mdr was updated with additional information received on 17-nov-2020.Additional information (18-nov-2020): quality controls (qc) recovered in range at the time of the event.The provided calibration curve was also inconspicuous.The issue was limited to one patient sample.Additional information (10-dec-2020): the affected patient sample was sent to siemens for investigation testing.The sample was rerun twice for albumin, generating correct results of 483 mg/l and 499 mg/l.No sample abnormalities were observed visually.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: BN PROSPEC SYSTEM
• Common Device Name: BN PROSPEC SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 10838477
• Report Number: 9610806-2020-00059
• Device Sequence Number: 2960168
• Product Code: JZW
• UDI-Device Identifier: 00630414002736
• UDI-Public: 00630414002736
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: BN PROSPEC SYSTEM
• Device Catalogue Number: 10465217
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR