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

Model Number MULTIFIBREN U

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 142665867
• Report Number: 9610806-2019-00042
• Device Sequence Number: 1
• Product Code: KQJ
• UDI-Device Identifier: 00842768017872
• UDI-Public: 00842768017872
• Combination Product (y/n): N
• PMA/PMN Number: K934326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1