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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE; INSULIN INFUSION PUMP ACCESSORY
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE; INSULIN INFUSION PUMP ACCESSORY Back to Search Results
Catalog Number 05206073001
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Hyperglycemia (1905)
Type of Reportable Event Malfunction
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.H3 other text : the customer discarded the used material.
 
Event or Problem Description
It was reported that the insulin cartridge leaked insulin into the cartridge compartment of the infusion device repeatedly leading to elevated blood glucose levels.
 
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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 Key18140034
Report Number3011393376-2023-02572
Device Sequence Number12760337
Product Code LZG
UDI-Device Identifier04015630882908
UDI-Public04015630882908
Combination Product (Y/N)N
Initial Reporter CountryGM
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Other,Foreign,Company Representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/15/2023
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 Date11/05/2024
Device Catalogue Number05206073001
Device Lot Number32492562
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/13/2023
Initial Report FDA Received Date11/15/2023
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured12/06/2022
Is the Device Labeled for Single Use? (Y/N) Yes
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNKNOWN INSULIN
Patient Age74 YR
Patient SexFemale
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