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

Model Number	DADE INNOVIN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The customer indicated the sample was checked for clots, hemolysis, icterus and lipemia and no issues were observed.The customer also indicated that quality controls recovered within expected ranges on the day of the event and that there were no error messages on the sysmex cs-5100 systems.Siemens determined that pre-analytical issues (specific sample characteristics, blood collection, transportation, and/or sample processing/handling in the laboratory) potentially contributed to the discordant, falsely elevated pt and pt inr results and discordant, falsely low pt % results.Siemens specialists were previously dispatched to the customer's site to evaluate and discuss pre-analytical handling conditions with the customer.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely elevated prothrombin time (pt) and pt international normalized ratio (inr) results were obtained on a patient sample using the dade innovin reagent on two sysmex cs-5100 systems.Additionally, discordant, falsely low pt % results were obtained on the same sample, using the same reagent.None of these results were reported to the physician(s).The sample was repeated, using the thromborel s reagent, resulting lower for pt and pt inr, and higher for pt %.The sample was repeated using the same dade innovin reagent lot and the same thromborel s reagent lot three times.The pt inr result of 2.65 was 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 and the discordant, falsely low 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: 8202382
• Report Number: 9610806-2018-00118
• Device Sequence Number: 11176947
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 12/28/2018

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: 04/20/2020
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 549711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR