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 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a customer care center (ccc).Siemens investigation determined that quality controls (qc) recovered in range and no hardware errors occurred at the time of the event.Sample integrity was acceptable.The sample tube used and the instrument tube type settings were appropriate as per the sysmex cs-2500 instructions for use (ifu).Pre-analytical factors such as inadequate mixing or centrifugation, other mishandling of the sample, or patient medication/history cannot be ruled out as contributing factors, as the issue was limited to one patient sample.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample on a sysmex cs-2500 system using dade actin fsl activated ptt reagent.The discordant result was flagged with an analysis over time flag.The sample was auto-repeated for aptt, also recovering falsely elevated.The sample was re-spun due to the high results and was repeated for aptt using the same system and reagent, recovering lower.This lower result was flagged with a defective sample volume error.The same sample was then repeated on an alternate sysmex cs-2500 system using dade actin fsl activated ptt reagent, recovering lower with no flags.This result was reported, as the correct result, to the physician(s).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: 10766778
• MDR Text Key: 214806329
• Report Number: 9610806-2020-00052
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (y/n): N
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 556968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• 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