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	04/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls for prothrombin time (pt) had a noise error, but were repeated and recovered in range.A siemens customer service engineer (cse) was dispatched to the customer site.The cse inspected the sysmex cs-2500 system and verified alignments and temperatures.The cse cleaned and calibrated the detection wells, inspected fluidics, and verified pressures/vacuum.The cse performed a precision run on the system which recovered acceptably.Sample integrity for the affected sample was visually acceptable.No other issues occurred after the cse's departure.An instrument issue cannot be excluded due to the noise error on the qc.Inadequate sample mixing, centrifugation or other mishandling of the sample also cannot be ruled out as contributing factors to the discordant results.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 discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a sysmex cs-2500 system using dade innovin reagent.The sample was automatically repeated for pt and inr, recovering lower, but the results were still falsely elevated.The automatic repeat results were reported to the physician(s).The sample was retested twice for pt and inr on the same system, recovering lower.The lower pt and inr results were reported, as the correct results, to the physician(s).The sample was then repeated for pt and inr on a sysmex ca-1500 system, confirming the lower repeat results obtained on the sysmex cs-2500 system.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) 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: 11790885
• Report Number: 9610806-2021-00042
• Device Sequence Number: 14498260
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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: 08/22/2022
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549759A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1