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

Model Number	BERICHROM HEPARIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 21-nov-2017, a siemens healthcare diagnostics (siemens) customer service engineer (cse) was dispatched to the customer site and performed a preventative maintenance on the sysmex ca-1500 system.The operator declined further investigation and since (b)(6) 2017, the operator discontinued running the heparin unfractionated (uf) assay.Since the operator refused further investigation, siemens healthcare diagnostics (siemens) cannot determine the cause of the discordant, falsely low heparin uf result.No further evaluation of this device or reagent is required.
Event or Problem Description
A discordant, falsely low heparin unfractionated (uf) result was obtained on a patient sample on the sysmex ca-1500 system.This result was reported to the physician, who did not question the result.The sample was sent to alternate facility and tested for heparin uf.An expected, higher heparin uf result was obtained on the patient sample.A corrected report was not provided for this patient.The patient's heparin treatment was not adjusted due to the discordant result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin uf result.

• Brand Name: BERICHROM HEPARIN
• Common Device Name: BERICHROM HEPARIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7158642
• Report Number: 9610806-2018-00001
• Device Sequence Number: 19017229
• Product Code: KFF
• UDI-Device Identifier: 00842768012945
• UDI-Public: 00842768012945
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K925200
• 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): 01/02/2018

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: 02/12/2020
• Device Model Number: BERICHROM HEPARIN
• Device Catalogue Number: 10446620
• Device Lot Number: 47293
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1