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

Model Number	BN PROSPEC SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The bn prospec system was not under a service contract and the instrument had not been serviced since november 2019.Examination of the system error log showed that there was a pipette error, sample id error, and sample missing error at the time of the event.The log shows that the sample rotor cover was subsequently opened and the emergency stop was activated.It cannot be ruled out that this interaction contributed to the discordant result.The issue was limited to samples from one patient, so a sample specific issue also cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated albumin (serum) result and a discordant, falsely low albumin (cerebrospinal fluid (csf)) result were obtained on a serum sample and a csf sample from the same patient run on a bn prospec system.The discordant results were not reported to the physician(s).The following day the serum and the csf sample were repeated for albumin.The albumin (serum) result recovered lower and the albumin (csf) result recovered higher.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant albumin (serum) and albumin (csf) results.

• 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
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; registration number: 300360107; am kronberger hang 3; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 15302583
• Report Number: 9610806-2022-00047
• Device Sequence Number: 17720761
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 10462292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female