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

Model Number	DADE INNOVIN
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range before the discordant result was obtained.Qc was measured again after the discordant result was obtained and recovered out of range.The reagent vial was then exchanged, after which qc recovered in range.The customer aliquots reagent into super-long diffusion (sld) vials, and the reagent stays in sld vials while on board the system.Sld vials are not allowed for use with dade innovin reagent on the sysmex ca-660 system.The issue was resolved after exchanging the reagent on the system.The cause of the event is use error.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated 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 was given fresh frozen plasma during brain surgery based on the discordant, falsely elevated inr result.The sample was repeated for inr, recovering lower.The lower result was reported, as the correct result, to the physician(s).There are no known reports of adverse health consequences due to the administration of fresh frozen plasma.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range before the discordant result was obtained.Qc was measured again after the discordant result was obtained and recovered out of range.The reagent vial was then exchanged, after which qc recovered in range.The customer aliquots reagent into super-long diffusion (sld) vials, and the reagent stays in sld vials while on board the system.Sld vials are not allowed for use with dade innovin reagent on the sysmex ca-660 system.The issue was resolved after exchanging the reagent on the system.The cause of the event is use error.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated 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 was given fresh frozen plasma during brain surgery based on the discordant, falsely elevated inr result.The sample was repeated for inr, recovering lower.The lower result was reported, as the correct result, to the physician(s).There are no known reports of adverse health consequences due to the administration of fresh frozen plasma.

• 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: 13018346
• Report Number: 9610806-2021-00076
• Device Sequence Number: 17319557
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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: 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): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 12/16/2021
• 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 Age: 42 YR
• Patient Sex: Female