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

Model Number	DADE INNOVIN
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) to report that discordant, falsely elevated prothrombin time (pt) and pt international normalized ratio results were obtained on a sysmex cs-2100i system using dade innovin reagent.The cause of the discordant, falsely elevated prothrombin time (pt) and pt international normalized ratio results is unknown.Siemens is investigating the event.
Event or Problem Description
Discordant, falsely elevated prothrombin time (pt) and pt international normalized (inr) results were obtained on the sysmex cs-2100i system, using the dade innovin reagent.The discordant results were reported to the physician(s), who questioned the results.The patient was sent to an alternate laboratory, where the patient was redrawn and the new sample was run on a non-siemens system resulting, lower.The results obtained on the non-siemens system were reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated pt and pt inr results.
Additional Manufacturer Narrative
Additional information (29 -october-2018): siemens further investigated the event and determined that the overall system condition is good and there was no indication of a system malfunction.The dade innovin reagent is lupus sensitive.Siemens found in the system backup file that the sample id (b)(6) was measured on 2018-10-05 four times in micro mode.The second measurement at 11:44 does not fit to the other measurement in regards to the result.All other measurements resulted in no coagulation and this could be a second measurement issue.Siemens determined that quality controls (qcs) recovered within expected specifications on the day of the event and that maintenance was performed regularly.The cause of the discordant, falsely elevated prothrombin time (pt) and pt international normalized (inr) results is unknown.Corrected information (29-october-2018): sample id (b)(6).The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7996692
• Report Number: 9610806-2018-00107
• Device Sequence Number: 427928
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 09/01/2019
• Device Model Number: DADE INNOVIN
• Device Lot Number: 539395A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR