MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH MULTIFIBREN U

Model Number	MULTIFIBREN U
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that discordant, falsely elevated fibrinogen results were obtained on patient samples using multifibren u reagent on an atellica coag 360 system.Quality controls (qcs) were within acceptable ranges prior to and after the discordant results were obtained.The customer reported that the repeat results were obtained at another laboratory on a sysmex cs-5100 system using dade thrombin reagent.Siemens is investigating the issue.
Event or Problem Description
Three discordant, falsely elevated fibrinogen results were obtained on three patient samples using multifibren u reagent on an atellica coag 360 system.The discordant results were reported to the physician(s).Two of the three samples were repeated using the fib multi u low method with the same multifibren u reagent on the same atellica coag 360 system, resulting lower.The same three samples were repeated at another laboratory on a sysmex cs-5100 system using dade thrombin reagent, also resulting lower.The customer did not indicate if the repeat results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated fibrinogen results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00042 on 04-apr-2019.Siemens filed the first supplemental mdr 9610806-2019-00042_s1 on 08-may-2019.Additional information (14-may-2019): siemens performed additional testing with the affected patient samples received from the customer site.Three of the samples received (samples 3, 4 and 7) recovered below the reference range when run for fibrinogen using multifibren u reagent on the atellica coag 360 system.The same three samples were run for fibrinogen on the atellica coag 360 system using dade thrombin reagent and recovered low.Fibrinogen results also recovered low when run using a sysmex cs-5100 system with dade thrombin reagent.However, when the same three samples were measured with test thrombin and batroxobin, the results recovered above the reference range.All reference controls recovered within range.Therefore, the cause of the discordant results was most likely sample specific.As per the multifibren u instructions for use (ifu): degradation products of fibrin (ogen) lead to prolonged coagulation times and therefore to diminished recovery of fibrinogen.Therapy with direct thrombin inhibitors may contribute to diminished recovery.The result code and conclusion code in section h6 were updated based on the additional information.The reagent is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00042 on 04-apr-2019.Additional information (10-apr-2019): siemens further investigated the issue.For patient 3 (903070274p), the result of 1.2 g/l seems to be the mean value calculated out of the measurement of fib multi u (1.2 g/l) and fib multi u low (0.9 g/l), which is not recommended.The kinetics of both measurements were as expected.The result for the fib multi u low has the flag "sample tube under filled", which is due to the fact that the sample has been placed on the instrument for the second time.This result also has the flag "sample tube under filled" and the flag "expired reagent used".Siemens has received the affected patient samples from the customer site for further investigation.Siemens is investigating the issue.

• Brand Name: MULTIFIBREN U
• Common Device Name: MULTIFIBREN U
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8482833
• Report Number: 9610806-2019-00042
• Device Sequence Number: 1783510
• Product Code: KQJ
• UDI-Device Identifier: 00842768017872
• UDI-Public: 00842768017872
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K934326
• 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,Followup,Followup
• Report Date (Section B): 06/06/2019

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 Expiration Date: 09/12/2020
• Device Model Number: MULTIFIBREN U
• Device Catalogue Number: 10446691
• Device Lot Number: 539041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 04/10/2019; 05/14/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/08/2019; 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1