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

Model Number	BERICHROM HEPARIN
Medical Device Problem Codes	Imprecision (1307); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
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) result and quality control (qc) imprecision on the sysmex ca-1500 system.The cse observed a crack on the edge of the optical filter on the sysmex ca-1500 system and replaced the optical filter.The cse also verified the z adjustment on the piercer at the feeder position, verified that the lamp unit #3 box was internally clean, removed and cleaned filters, cleaned fiber end, verified the lamp stability, during the lamp calibration, with water in the 4 cuvettes, adjusted the reagent dispenser to the right of the center in the reaction vessel and lowered the reagent dispenser to miss the spring on catcher by 1 to 2 mm.After replacing the optical filter and performing the adjustments on the sysmex ca-1500 system, the cse ran calibration, qc, and performed three precision studies using control level 1, control level 2 and patient samples.The calibration, qc and precision studies recovered within expected ranges in micro mode and outside of expected ranges in normal mode.The operator declined further investigation and stopped running the heparin uf assay.The filter malfunction potentially contributed to the discordant result and qc imprecision.No further evaluation of these systems or reagent is required.
Event or Problem Description
Imprecise and out of range heparin unfractionated (uf) quality control (qc) results were obtained on the sysmex ca-1500 system.During this time, a patient sample was tested for heparin uf, resulting in a discordant, falsely low heparin uf result.This result was reported to the physician, who did not question the result.The patient's blood was redrawn and run on an alternate system, sysmex ca-1500 system, using same reagent lot.A higher heparin uf result, within therapeutic range, was obtained using the alternate system.It is unknown if the redrawn result was the correct result as the operator was also experiencing issues with the alternate system.The operator indicated that a corrected report was provided for this patient as the pharmacy indicated that the patient was on heparin treatment when the discordant result was reported.However, the corrected result is unknown.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin uf result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics (siemens) filed the initial on 27-dec-2017.Additional information (08-jan-2018): upon further investigation, siemens determined that the operator reported a discordant heparin unfractionated (uf) that was less than the limit of detection for the assay.Based on the berichrom heparin's instructions for use (ifu), "the limit of detection for an unfractionated heparin is 0.05 iu/ml".The operator reported a heparin uf result of 0.02 iu/ml.Section h6 has been updated to reflect this information.

• 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: 7149214
• Report Number: 9610806-2017-00151
• Device Sequence Number: 1917705
• 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,Followup
• Report Date (Section B): 02/02/2018

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
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR