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	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed n latex cystatin c (n cysc) result was obtained on a patient sample on a bn prospec system.Quality control and calibration were acceptable on the day of event.The customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse observed that the probe was mispositioned.The cse corrected the probe alignment.Then, the cse ran quality controls, which recovered within acceptable ranges.Siemens evaluated the instrument data and determined that there were no hardware errors generated by the instrument.The cause of the falsely depressed n cysc result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A falsely depressed n latex cystatin c (n cysc) result was obtained on a patient sample on a bn prospec system.The initial result was reported to the physician(s), who questioned the result.On the following day, the sample was reprocessed on the original instrument twice.The repeat results were reported as correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to a falsely depressed n cysc result.

• 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; am kronberger hang 3; registration number: 300360107; schwalbach 65824 ; GM 65824
• Manufacturer Contact: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 17539626
• Report Number: 9610806-2023-00011
• Device Sequence Number: 12337973
• 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): 08/14/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 08/14/2023
• 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 Sex: Unknown