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

Model Number	DADE ACTIN FSL ACTIVATED PTT REAGENT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that she sustained a small cut on her hand from a broken reagent vial.There were no reports of damage to the outside shipping box and the customer indicated that she did not find additional broken reagent vials in other reagent boxes of the same shipment.Siemens investigated whether there were additional reports of broken dade actin fsl activated ptt reagent vials with lot 556910a and found no issue.Siemens was unable to rule out the customer's handling, transport, storage or packaging of the reagent box to be the cause of the broken reagent vials.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that she sustained a small cut on her hand from broken reagent vials when opening a dade actin fsl activated ptt reagent box.The customer washed the injury with water and soap and applied a bandage.No additional medical intervention was required by the customer.The customer indicated that she disposed of the broken reagent vials; upon inspection of other reagent boxes, the customer determined that there were no other broken reagent vials.There are no known reports of medical intervention or adverse health consequences due to the customer's injury to the hand.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Common Device Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7709777
• Report Number: 9610806-2018-00076
• Device Sequence Number: 2770620
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/23/2018

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: 01/30/2019
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 556910A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR