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

Catalog Number 10873535

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

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 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
• Type of Device: INNOVANCE HEPARIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, gm 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, gm 35041 ; GM 35041
• Manufacturer Contact: loriann russo ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242287
• MDR Report Key: 7409215
• MDR Text Key: 105277559
• Report Number: 9610806-2018-00040
• Device Sequence Number: 1
• Product Code: KFF
• UDI-Device Identifier: 00842768017438
• UDI-Public: 00842768017438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2019
• Device Catalogue Number: 10873535
• Device Lot Number: 47758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1