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 Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that insulin was leaking from the insulin cartridge into the cartridge compartment of the infusion device.The patient suffered from hyperglycemia, administered too much insulin and went into hypoglycemia.The exact blood glucose values are not known.The user was taken to hospital and hospitalized for four days.The patient's doctor cited the pump as the cause of the leakage.The treatment administered at the hospital is unknown.

• 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: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 19749718
• Report Number: 3011393376-2024-01461
• Device Sequence Number: 8987685
• Product Code: LZG
• UDI-Device Identifier: 04015630882755
• UDI-Public: 04015630882755
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/26/2025
• Device Catalogue Number: 04949935001
• Device Lot Number: 32174343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSULIN
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 75 KG