MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Model Number	DADE INNOVIN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens was contacted by sysmex (b)(4) regarding this event.Quality controls (qc) recovered in range at the time of the event and all reaction kinetics were evaluated correctly by the system software.Prothrombin time was the only assay affected.Proton pump inhibitor therapy would unlikely have affected the results using dade innovin.However, antiphospholipid antibodies present in the patient sample can cause falsely elevated prothrombin time results.As per the dade innovin reagent instructions for use (ifu): "inhibitors such as lupus anticoagulant may interfere with the prothrombin time and result for example in inrs that do not reflect the exact degree of anticoagulation".The presence of antiphospholipid antibodies explains the prothrombin time result discrepancies for this patient.The cause of the event is a sample specific issue.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2021-00050 was filed for the discordant result obtained on (b)(6) 2021.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) result, and a discordant, falsely low prothrombin time percent (pt%) result were obtained on a sysmex cs-5100 system using dade innovin reagent.The results did not match with results obtained on a non-siemens system using a non-siemens reagent the day prior.The results were reported to the physician(s) and were questioned.A new sample was drawn from the patient and was run for pt, inr, and pt% on an alternate sysmex cs-5100 system using dade innovin reagent, as well as on a non-siemens system using a non-siemens reagent at an alternate laboratory.The pt and inr recovered falsely high and the pt% recovered falsely low, compared to the results obtained on the non-siemens system.Three days later, after the patient had started vitamin k administration and had switched their anticoagulant to lovenox, a new sample was drawn and was run for pt% on a sysmex cs-5100 sysem using dade innovin reagent as well as on a non-siemens system using a non-siemens reagent.The pt% recovered falsely low compared to the results obtained on the non-siemens system.There are no known reports of adverse health consequences due to the discordant prothrombin time (pt), prothrombin time international normalized ratio (inr), and prothrombin time percent (pt%) results.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 12009020
• Report Number: 9610806-2021-00049
• Device Sequence Number: 14252387
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K974343
• 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,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: 10/01/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1