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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) were reported to have recovered in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse repeated qc, which recovered out range and generated "no reaction" error flags.The cse reconstituted fresh reagents and then reran qc, which recovered in range.The cse assessed that the reagent had been reconstituted next to the thrombin reagent, and was therefore contaminated.Since fresh reagent was loaded on to the system, qc has passed specifications and there have been no issues with other patient results.Reagent handling issues cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely low activated partial thromboplastin time (aptt) results were obtained on four patient samples from four different patients on a bcs xp system using dade actin fsl activated ptt reagent.The discordant results were reported to the physician(s) and were questioned.The samples were repeated for aptt on an alternate bcs xp system, recovering higher.The higher results were reported, as the correct results, to the physician(s).One of the four patients had a new sample drawn which was run for aptt on the alternate bcs xp, matching the higher repeat result.There are no known reports of patient intervention or adverse health consequences due to the discordant 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
• 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 ; 9144153450
• MDR Report Key: 13599193
• Report Number: 9610806-2022-00011
• Device Sequence Number: 5833427
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 12/08/2022
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 562640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male