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

Model Number	DADE ACTIN FSL ACTIVATED PTT REAGENT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range on both days, and the base height (bh) and the delta height (dh) for the qc compared well.However, significant differences were observed when comparing the bh and dh levels for the patient sample aptt results from (b)(6) 2020 and (b)(6) 2020.This indicates that a potential sample handling or pre-analytical issue may have occurred on (b)(6) 2020.The cause of the event is unknown.The reagent is performing according to specification.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely elevated activated partial thromboplastin time (aptt) results were obtained on six patient samples on a sysmex ca-660 system using dade actin fsl activated ptt reagent.The discordant results were reported to the physician(s).The samples were refrigerated and rerun the following day for aptt, as the customer was questioning the results.The repeated samples recovered lower.These repeat results were considered to be the correct results.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated activated partial thromboplastin time (aptt) results.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Common Device Name: DADE ACTIN FSL 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: 10896329
• Report Number: 9610806-2020-00058
• Device Sequence Number: 11592018
• Product Code: GGW
• UDI-Device Identifier: 00842768003875
• UDI-Public: 00842768003875
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K863594
• 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): 11/24/2020

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: 11/25/2021
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445713
• Device Lot Number: 562609A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1