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

Model Number DADE ACTIN FSL ACTIVATED PTT REAGENT

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 10896329
• MDR Text Key: 225138880
• Report Number: 9610806-2020-00058
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003875
• UDI-Public: 00842768003875
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K863594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• 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: Reuse
• Patient Sequence Number: 1