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

Model Number	04949935001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the piston rod of the infusion device was wet as if insulin leaked from the cartridge.
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.

• 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: 14408910
• Report Number: 3011393376-2022-01467
• Device Sequence Number: 5538878
• 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): 07/13/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 04949935001
• Device Catalogue Number: 04949935001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 07/13/2022
• 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: 10 YR
• Patient Sex: Female