MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE HEPARIN

Catalog Number	10873535
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, low heparin patient sample result on the bcs xp analyzer.No product non-conformance could be identified and a possible cause of the event may be sample specific or related to sample handling.Siemens requested a backup file and clarification of the type of heparin administered, but the customer declined to provide further information and stated that they have had no further issues with other samples.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, low heparin patient result (0.02 iu/ml) using innovance heparin kit lot 47758 was generated on the bcs xp analyzer.This patient result was not reported to the physician.The same patient sample was remixed and recentrifuged on the same day and run on the same bcs xp analyzer.A higher heparin patient result of 0.44 iu/ml (repeat result 1) was generated, but not reported to the physician.The same sample was repeated again on the same bcs xp analyzer and a heparin patient result of 0.45 iu/ml (repeat result 2) was generated and reported to the physician.The repeat heparin results matched the clinical expectation of the patient.Quality control values were within range before testing.There was no known impact or adverse health consequence to the patient due to the low innovance heparin result as the result was not reported.

• Brand Name: INNOVANCE HEPARIN
• Common Device Name: INNOVANCE HEPARIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, gm 35041 ; GM 35041
• MDR Report Key: 7409215
• Report Number: 9610806-2018-00040
• Device Sequence Number: 19090410
• Product Code: KFF
• UDI-Device Identifier: 00842768017438
• UDI-Public: 00842768017438
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162540
• 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): 04/09/2018

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: 05/03/2019
• Device Catalogue Number: 10873535
• Device Lot Number: 47758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1