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

Model Number	BERICHROM HEPARIN
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that five discordant, falsely low heparin results and one discordant, falsely high heparin result were obtained on six patient samples on a bcs xp system using berichrom heparin reagent.The lab's technical application specialist (tas) reported to siemens that the issue was due to a reagent handling issue.The customer was overdue for a calibration at the time of the event.The customer also leaves the reagent on the analyzer when running quality controls (qc) but places it back in the refrigerator afterward.Per the tas and the customer, the issue was resolved by discussing proper reagent handling.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Five discordant, falsely low heparin results and one discordant, falsely high heparin result were obtained on six patient samples on a bcs xp system using berichrom heparin reagent.The discordant results were reported to the physician(s).Two of the affected patients had their heparin dose increased due to the discordant, falsely low heparin results.The pharmacy later questioned the reported results.The patients were later redrawn and retested for heparin, resulting either higher or lower, respectively.The repeat results were reported, as the correct results, to the physician(s).There are no reports of adverse health consequences for any of the six patients due to the discordant, falsely low heparin results and the discordant, falsely high heparin result.No adverse health consequences were reported for the two patients who received an increase in heparin dose 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: 8925596
• Report Number: 9610806-2019-00068
• Device Sequence Number: 2128387
• Product Code: KFF
• UDI-Device Identifier: 00842768012945
• UDI-Public: 00842768012945
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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: 03/19/2021
• Device Model Number: BERICHROM HEPARIN
• Device Catalogue Number: 10446620
• Device Lot Number: 48682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1