MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE; INSULIN INFUSION PUMP ACCESSORY

Catalog Number	04949935001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insulin cartridge leaked insulin into the cartridge compartment of the infusion device.The user alleged that a leakage occurred with two cartridges from the same box/lot.
Additional Manufacturer Narrative
The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states the user reported that the insulin cartridges were not expired at the time of the event.H3 other text : shipment of complaint material from russia suspended indefinitely.

• Brand Name: ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE
• Common Device Name: INSULIN INFUSION PUMP ACCESSORY
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): CLINICO MEDICAL SP Z O.O.; ul. kocha 1; na; blonie 55-33 0; PL 55-330
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18094172
• Report Number: 3011393376-2023-02501
• Device Sequence Number: 6254365
• Product Code: LZG
• UDI-Device Identifier: 04015630882755
• UDI-Public: 04015630882755
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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: Lay User/Patient
• Device Expiration Date: 10/18/2023
• Device Catalogue Number: 04949935001
• Device Lot Number: 32465401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSULIN
• Patient Age: 38 YR
• Patient Sex: Male