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	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 10-jan-2018, a siemens healthcare diagnostics (siemens) customer service engineer (cse) was dispatched to the operator's site to determine the cause of different heparin unfractionated (uf) results obtained on a different patient on the bcs xp system.The operator replaced the standard human plasma (shp) calibrator and established a new calibration curve on (b)(6) 2018 and indicated that acceptable results were obtained using the new calibration curve.On 18-jan-2018, the operator indicated that different heparin uf results were obtained using the user defined method (udm) compared to the siemens' application of berichrom heparin reagent for two patient samples on (b)(6) 2018.Siemens obtained the assay procedure and definitions for the udm (assay procedure number 7021) and the siemens' application (assay procedure number 93) of the berichrom heparin reagent.Siemens reviewed the calibration curves that were established on (b)(6) 2017 and (b)(6) 2018 and determined that the assay procedures were acceptable.Siemens determined that the quality controls (qcs) and the calibration curve for assay procedure number 93 were within expected ranges.Siemens determined that assay procedure number 7021 is linked to the curve established for assay procedure number 93 and the last two points of the calibration curve is flat, which potentially contributed to some low raw value recovery for assay procedure number 7021.This potentially contributed to the different heparin uf results obtained using assay procedure number 7021.Siemens determined that assay procedure number 93 is performing within specifications.The cause of the event is unknown.The system and reagent are performing according to specifications.Mdr 9610806-2018-00021 was filed for the same event.
Event or Problem Description
Heparin unfractionated (uf) results, flagged with "results above measurement range", were obtained on 2 patient samples on the bcs xp system, using the berichrom heparin reagent.The same samples were rerun, using a user defined method (udm) of the berichrom heparin reagent, on the same system, resulting lower.Sample 822 was manually diluted with standard human plasma (shp) and run using the siemens' application of the berichrom heparin reagent, resulting higher than the repeat result.The result obtained using the manual dilution was not reported to the physician(s).The operator indicated that the patient of sample 822 was potentially redrawn and run at an alternate lab, recovering in a result of 0.91 iu/ml.The operator indicated that the expected results for these patients are unknown and that no corrected report was required since they did not report any discordant result.There are no known reports of patient intervention or adverse health consequences due to the different heparin uf results obtained on these samples.

• 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: 7234639
• Report Number: 9610806-2018-00022
• Device Sequence Number: 980707
• 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
• Report Date (Section B): 02/01/2018

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: 03/29/2020
• Device Model Number: BERICHROM HEPARIN
• Device Catalogue Number: 10446620
• Device Lot Number: 47486
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1