MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE HEPARIN

Model Number	INNOVANCE HEPARIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no instrument errors occurred at the time of the event.No sample issues were observed and no other assays were affected.Siemens is investigating the issue.Mdr 9610806-2021-00032 was filed for the discordant result obtained on (b)(6) 2021.
Event or Problem Description
A discordant, falsely low heparin result was obtained on a patient sample on a sysmex cs-2500 system using innovance heparin reagent.The result was flagged with a "lower report limit over" error.The patient had been started on heparin six hours before obtaining the discordant result.The heparin dosage was stopped the following day, after which a second discordant, falsely low heparin result was obtained.This result was also flagged with a "lower report limit over" error.Three hours after obtaining this result, the patient was started on heparin again.Two other samples from the patient were measured for heparin later the same day, recovering higher.These higher results were considered correct.Heparin infusion was stopped for the patient that night.For the following two days, eight samples from the same patient were measured for heparin, all recovering acceptably in line with changes in heparin dosage over the course of the two days.There are no known reports of adverse health consequences due to the discordant, falsely low heparin results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2021-00031 on 24-mar-2021.Additional information (25-mar-2021): the sample was collected in a 2.7 sodium citrate tube, and the tube setting in the software was set correctly.The customer centrifuged the sample at 5000 rpm for 5 minutes.However, this is not consistent with the innovance heparin instructions for use (ifu), which states that the sample should be spun for 15 minutes at 1500 or 2500 rpm.The quick braking of high speed centrifugation may cause platelets, red cells, and other cellular debris to re-suspend into the plasma portion of the sample.Inadequate mixing and collection, centrifugation or other mishandling of the sample cannot be excluded as contributing factors to the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Supplemental mdr 9610806-2021-00032 was also filed for the additional information obtained on 25-mar-2021.

• Brand Name: INNOVANCE HEPARIN
• Common Device Name: INNOVANCE HEPARIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 11563752
• Report Number: 9610806-2021-00031
• Device Sequence Number: 16882945
• Product Code: KFF
• UDI-Device Identifier: 00842768017438
• UDI-Public: 00842768017438
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K162540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 03/22/2022
• Device Model Number: INNOVANCE HEPARIN
• Device Catalogue Number: 10873535
• Device Lot Number: 50404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR