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 07/17/2017

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 with the sysmex cs-5100 system.The cause of the event is unknown.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 9610806-2017-00085, and mdr 9610806-2017-00086 were filed for the same event.

Event Description

Multiple activated partial thromboplastin time (aptt) results were obtained on multiple patient samples on a sysmex cs-5100 system.It is unknown whether these results were reported to the physician and it is unknown whether these results were discordant.On (b)(6) 2017, different aptt results from other samples of the same patient were reported to the physician.The customer indicated that the results obtained on (b)(6) 2017 were the correct results for this patient.There are no known reports of patient intervention or adverse health consequences due to the 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: 6789784
• MDR Text Key: 82709081
• Report Number: 9610806-2017-00087
• 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