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 Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range at the time of the event.All discordant, falsely depressed sample results were flagged with a y flag.As per the bn prospec instruction manual, results with a y flag can only be released if a sufficient sample volume is assured and the result recovers within the measuring range.All discordant, falsely depressed results recovered below the initial measuring range.Therefore, the reporting of the discordant, falsely depressed flc type kappa and flc type lambda results can be attributed to use error.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Five discordant, falsely depressed free light chains (flc) type kappa results and four discordant, falsely depressed flc type lambda results were obtained on patient samples on a bn prospec system.The discordant results were reported to the physician(s).Four days later, the samples were rerun for flc type kappa and flc type lambda on the same bn prospec system, resulting higher.These results were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the five discordant, falsely depressed flc type kappa results and four discordant, falsely depressed flc type lambda 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: 9922652
• Report Number: 9610806-2020-00012
• Device Sequence Number: 14157464
• Product Code: JZW
• UDI-Device Identifier: 00630414002736
• UDI-Public: 00630414002736
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K001647
• Number of Events Summarized: 1
• Summary Report (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): 04/03/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1