MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE D-DIMER CONTROLS

Model Number INNOVANCE D-DIMER CONTROLS

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Siemens has reviewed the current instructions for use (ifu) and safety data sheet (sds) for the innovance d-dimer controls.No warnings or precautions are given within the ifu with regards to a potential allergic reaction, skin irritation or rash occurring if the reagent comes in contact with the skin.The current sds sheet indicates that it may produce an allergic reaction.The concentrations of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2h-isothiazol-3-one within the innovance d-dimer controls are classified as skin sensitizers only in the (b)(6) union (eu), (b)(6).Therefore the sds and ifu were found to be not compliant with european regulation (ec) no (b)(4).The united states (us) product labeling is compliant with us regulations since this concentration of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2h-isothiazol-3-one does not require hazard statements.

Event Description

While reconstituting the innovance d-dimer control material, the customer splashed herself with 3-4 drops of innovance d-dimer control material on her wrist, and her skin turned red.The customer was wearing personal protective equipment (ppe), including gloves, at the time of the event.The customer went to the emergency room and was treated with an injection of polaramine.The skin redness went away after receiving the injection.There are no known reports of adverse health consequences due to this event.

• Brand Name: INNOVANCE D-DIMER CONTROLS
• Type of Device: INNOVANCE D-DIMER CONTROLS
• 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: 14280350
• MDR Text Key: 290782975
• Report Number: 9610806-2022-00023
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K081732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2023
• Device Model Number: INNOVANCE D-DIMER CONTROLS
• Device Catalogue Number: 10446005
• Device Lot Number: 00702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 05/04/2022
• 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
• Patient Sex: Female