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

Catalog Number	10445706
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics has investigated the provided information and assessed the discordant, high prothrombin time / international normalized ratio (pt/inr) patient sample result on the ca-660 analyzer.A sample handling issue cannot be ruled out such as improper mixing post blood draw.Improper mixing may cause poor anticoagulation or anticoagulant to be in the upper portion of the plasma sample, thus increasing clot time.Pour over action into a cup provides some mixing of plasma, even though the tube was not remixed and respun prior to repeat from the cup of original sample 1.There is no indication of reagent or instrument malfunction as pt quality control was within range, and no other samples were affected.No product non-conformance could be identified as the issue is sample related.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, high prothrombin time / international normalized ratio (pt/inr) patient sample result of 61.9 seconds/ 5.85 inr was generated on a ca-660 analyzer.The discordant, high pt/inr result was reported to the physician and questioned.Another two samples (samples 2 and 3) were drawn from the patient and run on the same ca-660 analyzer.Lower pt/inr results were generated.In addition, the original sample was rerun on the same system and also generated a lower pt/inr result.There are no reports of patient intervention or adverse health consequence due to the discordant, high pt/inr result.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 6964422
• Report Number: 9610806-2017-00122
• Device Sequence Number: 1324711
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/20/2017

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: 04/28/2018
• Device Catalogue Number: 10445706
• Device Lot Number: 539353A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR