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	04/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc) and reported that discordant, falsely low heparin unfractionated results were obtained on 2 patient samples using the berichrom heparin reagent.The customer reported that these samples were run before it was time to run quality controls (qcs) and that two other patient samples were processed prior to the affected patient samples without issues.The customer reported that they ran qcs and the affected patient samples after they replaced the reagents with fresh reagents; the qcs and patient results recovered as expected.Siemens is investigating the issue.
Event or Problem Description
Discordant, falsely low heparin unfractionated (uf) results were obtained on two patient samples on the bcs xp system using the berichrom heparin reagent.These results were autoverified by the system and sent to the hospital's laboratory information system (lis).The customer noticed that these results were discordant before they were reported to the physician(s).The customer replaced the reagents with fresh reagents and reran the samples; the repeat results were higher than the initial results and were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin uf results.
Additional Manufacturer Narrative
Additional information (15-may-2018): siemens investigated the system's data logs and determined that the calibration data recovered acceptably on the day of the event.Siemens observed that the reagent was ejected and loaded 4 times between the initial analysis of sample id (b)(4) and sample id (b)(4) and the purpose of this is unknown.The customer did not provide the time in which the reagent vials were reconstituted and there is no indication that the reagent was on-board past the validated on-board stability time.Siemens determined that the presence of froth, foam, or small bubbles in the reagent vials potentially led to inadequate reagent aspiration, causing the discordant, falsely low heparin unfractionated (uf) results and out of range quality control recoveries.The customer did not provide the affected samples for further investigation and there was no indication of a system or reagent issue.The system and reagent are performing according to specifications.No further evaluation of these devices is required.

• 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: 7500805
• Report Number: 9610806-2018-00046
• Device Sequence Number: 1717958
• Product Code: KFF
• UDI-Device Identifier: 00842768012945
• UDI-Public: 00842768012945
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 06/01/2018

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: 06/18/2020
• Device Model Number: BERICHROM HEPARIN
• Device Catalogue Number: 10446620
• Device Lot Number: 47855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1