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

Model Number DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2017

Event Type  malfunction  

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 on 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 9610806-2017-00085, mdr 9610806-2017-00086, and mdr 9610806-2017-00087 were filed for the same event.

Event 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 the time (in seconds) that corresponded to 50% of the coagulation curve for one sample to the physician.The patient blood was redrawn twice and run on the same system, resulting in two aptt results.A discordant, falsely low aptt result and a correct aptt result were reported to the physician.The physician misinterpreted the system's early reaction error as short coagulation time.The patient blood was redrawn again on the next day and run on the same system.An aptt result without flag(s) was obtained and provided to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt results reported to the physician.

• Brand Name: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Type of Device: 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; D-350 41; GM D-35041
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 6789733
• MDR Text Key: 83686048
• Report Number: 9610806-2017-00084
• Device Sequence Number: 1
• Product Code: GFO
• UDI-Device Identifier: 00842768003851
• UDI-Public: 00842768003851
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K760318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR