MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT

Model Number	DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
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	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.(siemens) analyzed sysmex cs-5100 system backup files provided by the customer.Siemens did not identify any systemic issues with the sysmex cs-5100 system.The system produced non-numerical aptt results, which signify that "analysis result could not be obtained due to errors and other problems".Based on the sysmex cs-5100 system operator's guide, the results were flagged because "an abnormal reaction was detected at the initial stage of the aptt coagulation reaction" and "the coagulation reaction was not detectable, due to low fibrinogen concentration, an anticoagulant sample or a reagent problem.The operator should "check the coagulation curve and follow the judgment criteria for your institution.Alternatively, check the volumes of sample and reagent, then repeat the test." the operator incorrectly reported the time (in seconds) that corresponded to 50% of the coagulation curve to the physician.The cause of the event is due to user error.The instrument and reagents are performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2017-00083, mdr 9610806-2017-00084, mdr 9610806-2017-00086, and mdr 9610806-2017-00087 were filed for the same event.
Event or Problem Description
Non-numerical flagged activated partial thromboplastin time (aptt) results were obtained on two patient samples on the sysmex cs-5100 system.The customer incorrectly reported 2 of 3 non-numerical aptt results to the physician by reporting the time (in seconds) that corresponded to 50% of the coagulation curve.One patient sample was re-run on the same system twice, resulting in two aptt results.A discordant, falsely low aptt result, obtained by adding polybrene, and a correct aptt result were reported to the physician.The physician misinterpreted the system's early reaction error as short coagulation time.On the previous day, the customer reported a correct aptt result to the physician that was obtained on another sample from the same patient.There are no known reports of patient intervention or adverse health consequences due to the aptt results that were reported to the physician.

• Brand Name: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Common Device Name: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 6789758
• Report Number: 9610806-2017-00085
• Device Sequence Number: 139193
• Product Code: GFO
• UDI-Device Identifier: 00842768003851
• UDI-Public: 00842768003851
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K760318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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: 11/30/2018
• Device Model Number: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Device Catalogue Number: 10445711
• Device Lot Number: 557236A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR