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

Model Number	DADE ACTIN FS ACTIVATED PTT REAGENT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The customer has stopped using the incorrect reagent.The cause of the event is use error, as the customer incorrectly used dade actin fs activated ptt reagent instead of dade actin fsl activated ptt reagent.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer failed an american proficiency institute (api) survey for activated partial thromboplastin time (aptt).The customer realized that although their sysmex ca-660 system was set up to run dade actin fsl activated ptt reagent, they were incorrectly using dade actin fs activated ptt reagent.The customer has incorrectly used dade actin fs activated ptt reagent since january 2020.No aptt patient results have been questioned by the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: DADE ACTIN FS ACTIVATED PTT REAGENT
• Common Device Name: DADE ACTIN FS ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 11570107
• Report Number: 9610806-2021-00033
• Device Sequence Number: 4139138
• Product Code: GGW
• UDI-Device Identifier: 00842768003868
• UDI-Public: 00842768003868
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K811589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 07/03/2021
• Device Model Number: DADE ACTIN FS ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445712
• Device Lot Number: 538567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1