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 Codes	Off-Label Use (1494); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely low activated partial thromboplastin time (aptt) result was obtained on a patient sample on a bcs xp system using dade actin fsl activated ptt reagent.The customer was performing correlation studies with a new lot of actin fsl at the time of the discrepant patient result.A new lot of reagent that was being used for crossover studies was mixed with the current lot of reagent.Both current and new lots of reagent were both set as current on the system, and the system was potentially using the wrong reagents.Both current and new lots of reagent could have also potentially been blended together.This is off label use of the dade actin fsl activated ptt reagent.Quality controls (qc) were later run and recovered within range.Additionally, more than 30 patient samples were then run on the affected bcs xp system, and no other issues were found.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low activated partial thromboplastin time (aptt) result was obtained on a patient sample on a bcs xp system serial number: (b)(4) using dade actin fsl activated ptt reagent (lot number: 556936).The discordant result was reported to the physician(s).The customer later questioned the initial result.The original patient sample was repeated for aptt twice using the same bcs xp system serial number: (b)(4), resulting higher.The same sample was then repeated for aptt twice using an alternate bcs xp system serial number: (b)(4), resulting higher and confirming the repeat results from the first bcs xp system serial number: (b)(4).The repeat results from bcs xp system serial number: (b)(4) were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt result.

• 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: 8884602
• Report Number: 9610806-2019-00064
• Device Sequence Number: 11399982
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K863594
• Number of Events Summarized: 1
• Summary Report (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): 08/12/2019

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: 02/15/2020
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 556936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR