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	05/07/2024
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.
Additional Manufacturer Narrative
H3 other text : no product was returned for evaluation.

• 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 ; 3175212484
• MDR Report Key: 19459391
• Report Number: 3011393376-2024-01177
• Device Sequence Number: 7908231
• Product Code: LZG
• UDI-Device Identifier: 04015630882755
• UDI-Public: 04015630882755
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K043000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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 Catalogue Number: 04949935001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 111 KG