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	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the catcher box on the system and performed a precision run which recovered acceptably.A pre-analytical issue, such as a gradient in the initial patient sample draw caused by insufficient mixing, transportation, or sample handling, cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A non-numeric prothrombin time (pt) result flagged with a "no coagulation" error flag was obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The sample was repeated for pt on the same system with the same reagent, again giving a non-numeric result flagged with a "no coagulation" error flag.The sample was then repeated for pt on the same system with the same reagent, recovering falsely elevated.The sample was then repeated for pt on the same system with the same reagent, giving a non-numeric result flagged with a "no coagulation" error flag.The sample was then repeated for pt on the same system with the same reagent, recovering lower.The sample was then repeated for pt on the same system with the same reagent, recovering lower.The sample was then sent to an alternate hospital to be run for pt and prothrombin time international normalized ratio (inr).The pt result recovered lower.The pt and inr results obtained at the alternate hospital were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant 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
• 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: 13552450
• Report Number: 9610806-2022-00006
• Device Sequence Number: 20147732
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: 11/28/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/17/2022
• 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 Age: 78 YR
• Patient Sex: Male