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

Model Number	DADE INNOVIN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.(siemens) determined that the cause of the discordant prothrombin time (pt) results on two patient samples on the sysmex ca-1500 system was user error.After the discordant result was reported to the physician, the customer realized they did not spin the patient samples prior to running the pt test.Based on the dade innovin's instruction for use (ifu), "mix nine parts of freshly collected patient blood with one part of 0.11 or 0.13 mol/l (3.2 % or 3.8 %) sodium citrate solution.An evacuated tube system or syringe may be used.Centrifuge the blood specimen at 1500 x g for no less than 15 minutes at room temperature.Store in an unopened tube at room temperature.Do not store on ice or at 2 to 8 °c as cold activation of f vii may alter results.Plasma should be tested within 24 hours of blood collection.Samples should not stand at 37 °c for more than 5 minutes." the customer did not follow the dade innovin ifu and obtained non-numerical, flagged pt results.Once the customer spun the affected samples and ran the patients' plasma, correct results were obtained for both patients.Siemens also performed a data check, reviewed the customer's system settings and found no issues.The quality controls were within expected ranges at the time of the event.The system and reagent are performing according to specifications.No further evaluation of this system or reagent is required.
Event or Problem Description
Flagged non-numerical prothrombin time (pt) results and pt international normalized ratio (inr) results were obtained on two patient samples on the sysmex ca-1500 system.The same samples were automatically repeated on the same system.A discordant, falsely low pt result and a discordant, falsely low pt inr result were obtained on one patient sample (sample id (sid) (b)(6)), whereas non-numerical, flagged results were obtained on the other patient sample (sid: (b)(6)).The system automatically validated the discordant low results and the results were sent to the laboratory information system (lis) for sid (b)(6).The lis auto validated and reported the discordant results to the physician.The physician did not question the results since the results were corrected by the lab in a timely manner.No discordant results were reported on the other patient sample (sid (b)(6)).The customer realized that patient sample sid (b)(6) was not spun prior to running the pt test.Both samples were spun and repeated on the same system and expected results were obtained.Corrected final reports were provided to the physician.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
• MDR Report Key: 7053213
• Report Number: 9610806-2017-00133
• Device Sequence Number: 2037568
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 04/12/2019
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 539384
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1