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

Model Number	DADE INNOVIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant, falsely low prothrombin time international normalized ratio (inr) result was obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The discordant result was reported to the physician(s).The patient subsequently had a bleeding episode and was given vitamin k.The following day, the same sample was rerun for inr, recovering higher.The patient was then redrawn and the redrawn sample was run twice for inr, recovering higher than the initial discordant result.The higher inr results were reported, as the correct results, to the physician(s).There are no known reports of adverse health consequences due to the falsely low prothrombin time international normalized ratio (inr) result or due to the bleeding.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and haven't been verified.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no associated instrument errors occurred at the time of the event.Siemens is investigating the issue.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2022-00003 on 06-jan-2022.Additional information (07-jan-2022): qualty controls (qc) recovered in range, no instrument errors occurred, and the issue was limited to one patient sample.Inadequate sample collection, mixing, centrifugation or other mishandling of the sample cannot be ruled out as contributing factors to the event.The cause of the event is unknown.Additional information (11-jan-2022): section b5 of the mdr was updated to indicate that there was a delay in administering vitamin k and prothrombinex.The investigation findings and investigation conclusions codes in section h6 of the mdr were updated to reflect the additional information.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low prothrombin time international normalized ratio (inr) result was obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The discordant result was reported to the physician(s).The patient subsequently had a bleeding episode and was given vitamin k and prothrombinex.There was a delay in administering vitamin k and prothrombinex due to the low result.The following day, the same sample was rerun for inr, recovering higher.The patient was then redrawn and the redrawn sample was run twice for inr, recovering higher than the initial discordant result.The higher inr results were reported, as the correct results, to the physician(s).There are no known reports of adverse health consequences due to the falsely low prothrombin time international normalized ratio (inr) result, the delay in administering vitamin k and prothrombinex, or due to the bleeding.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and haven't been verified.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 13178845
• Report Number: 9610806-2022-00003
• Device Sequence Number: 4518334
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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 Expiration Date: 09/10/2023
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 549785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/01/2022
• 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 Sex: Unknown