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

Model Number INNOVANCE D-DIMER

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Laceration(s) (1946)

Event Date 05/24/2023

Event Type  malfunction  

Event Description

When the customer opened the innovance d-dimer diluent bottle (batch number: 568927), the reagent bottle suddenly shattered, cutting their left thumb.The customer had bandages applied to the wound at the hospital and received a tetanus injection that afternoon.The customer was wearing gloves at the time of the event.There are no known reports of adverse health consequences due to this event.

Manufacturer Narrative

Sysmex informed siemens that a customer sustained an injury to the hand while handling an innovance d-dimer diluent bottle.The glass of the bottle was found to be broken structurally.There was a breaking point on shoulder of glass vail.The label was applied correctly, and the glass pieces were attached to the label as well, indicating that the vial was appropriate while labelling.No other components in the innovance d-dimer kit were damaged.There were no reports of damage to the box.The manufacturing records as well as the log books of used equipment were reviewed.The lot was filled on two lines.The documents of one filling line recorded a disruption due to glass breakage within the screwing process.According to local work instruction all vials within an interruption within equipment must be discarded.It cannot be ruled out that the affected vial was inflicted with a hairline crack caused by screwing process.A hairline crack on the vial shoulder can cause the vial to be sensitive to mechanical impact.So it is possible that a minor impact such as opening the vial can lead to glass breakage.The cause of the event is unknown.

• Brand Name: INNOVANCE D-DIMER
• Type of Device: INNOVANCE D-DIMER
• 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: 17190749
• MDR Text Key: 317759985
• Report Number: 2432235-2023-00184
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445980
• Device Lot Number: 01214
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1