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	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).One quality control (qc) result on (b)(6) 2021 recovered high and out of range.Additional qc all recovered in range, and the calibration curves for the two reagent lots did not show any abnormalities.The samples were centrifuged correctly.No system abnormalities were identified.Discordant results were obtained using both the polypropylene and polystyrene sample tubes.There are no specifications or statements in the albumin's instructions for use nor in the bn prospec system instruction manual regarding the use of polystyrene tubes or polypropylene tubes.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2021-00056 and 9610806-2021-00057 were filed for discordant results obtained on (b)(6) 2021 and (b)(6) 2021, respectively.
Event or Problem Description
Three discordant, falsely elevated albumin results were obtained on a patient cerebrospinal fluid (csf) sample run in a polypropylene tube on a bn prospec system using n antiserum to albumin reagent.The discordant results were not reported to the physician(s).The sample was repeated for albumin csf in a polystyrene tube on the same system with the same reagent, recovering lower.The following day, the same sample was repeated for albumin csf in a polypropylene tube on the same bn prospec system using a new lot of n antiserum to albumin reagent, recovering falsely low.The sample was then repeated two additional times for albumin csf in a polystyrene tube on the same system with the same reagent, recovering higher.The results obtained in the polystyrene tube were considered correct.Two discordant, falsely low albumin results and one discordant, falsely elevated albumin result were obtained on a second patient csf sample run in a polypropylene tube on a bn prospec system using n antiserum to albumin reagent.The discordant results were not reported to the physician(s).The sample was repeated three times for albumin csf in a polystyrene tube on the same system with the same reagent, once recovering falsely high and twice recovering acceptably.The following day, the same sample was repeated for albumin csf in a polypropylene tube on the same bn prospec system using a new lot of n antiserum to albumin reagent, recovering falsely low.The sample was then repeated two additional times for albumin csf in a polystyrene tube on the same system with the same reagent, recovering higher.The lower albumin results obtained in the polystyrene tube were considered correct.A third patient csf sample was run two times for albumin in a polypropylene tube on a bn prospec system using n antiserum to albumin reagent.The following day, the same sample was repeated for albumin csf in a polypropylene tube on the same bn prospec system using a new lot of n antiserum to albumin reagent, recovering higher.The results were not reported to the physician(s).It is unknown what the correct albumin result was for this patient.Four discordant, falsely elevated albumin results were obtained on a fourth patient cerebrospinal fluid (csf) sample run in a polypropylene tube on a bn prospec system using n antiserum to albumin reagent.The discordant results were not reported to the physician(s).The sample was repeated four times for albumin csf in a polystyrene tube on the same system with the same reagent, recovering lower.The results obtained in the polystyrene tube were considered correct.There are no known reports of patient intervention or adverse health consequences due to the discordant 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
• MDR Report Key: 12333306
• Report Number: 9610806-2021-00055
• Device Sequence Number: 19521421
• Product Code: JZW
• UDI-Device Identifier: 00630414002736
• UDI-Public: 00630414002736
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1