MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BFT II ANALYZER

Model Number	BFT II ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant, falsely elevated prothrombin time international normalized ratio (inr) result was obtained on a patient sample on a bft ii analyzer using thromborel s reagent.The sample was repeated for inr two additional times using the same analyzer and reagent, also recovering falsely elevated.The falsely elevated results were reported to the physician(s) and were questioned.The same sample was rerun for inr at an alternate hospital using an unknown system and reagent, recovering lower.The lower result was considered to be the correct result.There are no known reports of patient intervention or adverse health consequences due to the discordant inr results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The customer indicated that normal level quality controls (qc) recovered in range at the time of the event, but did not provide qc results for other control levels.The issue was limited to one patient sample and no mechanical errors occurred at the time of the event.Inadequate sample collection, mixing, centrifugation or other mishandling of the sample cannot be ruled out contributing factors to the event.The cause of the event is unknown.The analyzer is performing according to specifications.No further evaluation of this device is required.

• Brand Name: BFT II ANALYZER
• Common Device Name: BFT II ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): LABITEC - LABOR BIOMEDICAL TECHNOLOGIES GMBH; registration #: 3003354497; an der strusbek 6; ahrensburg, D-229 26; GM D-22926
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 13691218
• Report Number: 9610806-2022-00013
• Device Sequence Number: 5480318
• Product Code: JPA
• UDI-Device Identifier: 00842768024887
• UDI-Public: 00842768024887
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K984501
• 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): 03/08/2022

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: BFT II ANALYZER
• Device Catalogue Number: 10458677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/08/2022
• 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: 66 YR
• Patient Sex: Male