MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Model Number	DADE INNOVIN
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sysmex informed siemens that a customer sustained an injury to the hand while handling a dade innovin reagent vial.All additional reagent boxes and vials that were included in the delivery box were examined; they were in good condition.Siemens searched for similar complaints from the manufacturing date of the reagent to 20-feb-2023 and found that no other similar complaints were received for this reagent lot.The customers facility's handling of the material, as well as transport, storage and packaging of the reagent, potentially contributed to the event.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Sysmex reported to siemens that a customer sustained an injury to the hand while opening a dade innovin vial, which was directly extracted from the packaging box.The customer demonstrated the neck of the vial was broken.The customer was then given a mini x-ray to ensure that there were no glass fragments in the wound.The wound was cleaned and disinfected and protected with steri-strips.No further treatment was necessary.The customer returned to work the same day.The customer was wearing a lab coat and latex gloves at the time of the incident.There are no known reports of adverse health consequences due to this event.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and have not been verified.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• 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: 16482208
• Report Number: 9610806-2023-00006
• Device Sequence Number: 7671321
• Product Code: GJS
• UDI-Device Identifier: 00842768003783
• UDI-Public: 00842768003783
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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: 09/23/2024
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445704
• Device Lot Number: 564606A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/03/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female