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

Model Number	BERICHROM HEPARIN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer's site to determine the cause of the discordant, falsely low heparin unfractionated (uf) results.The cse performed sample probe and reagent probe alignments and tested both probes for accurate pipetting.The cse ran and repeated 10 previously affected patient samples with no issues.The cse indicated that results recovered within precision and accuracy specifications and that internal quality controls recovered close to the mean.The cause of the discordant, falsely low heparin uf results is unknown.The system and reagent are performing according to specifications.No further evaluation of this system or reagent is required.
Event or Problem Description
Discordant, falsely low heparin unfractionated (uf) results were obtained on a patient sample on the bcs xp system.It is unknown whether all of the discordant results were flagged by the system.These results were not reported to the physician.The customer indicated that they reran the same sample on the same instrument until they obtained a result that matched the patient's clinical history.The repeated results recovered higher and the customer reported the highest flagged result to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin results.

• 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: 6970286
• Report Number: 9610806-2017-00118
• Device Sequence Number: 69122
• Product Code: KFF
• UDI-Device Identifier: 00842768012945
• UDI-Public: 00842768012945
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/23/2017

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: 10/26/2019
• Device Model Number: BERICHROM HEPARIN
• Device Catalogue Number: 10446620
• Device Lot Number: 46909
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1