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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK FLEXLINK INFUSION SET; SUBCUTANEOUS INFUSION SET
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ROCHE DIABETES CARE, INC. ACCU-CHEK FLEXLINK INFUSION SET; SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 03/30/2021
Event Type  Injury  
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 Description
It was reported that the cannula of the infusion set was not correctly inserted into the patient's skin resulting in hyperglycemia.The patient was admitted to the hospital for 2 days and treated with fluids intravenously.The blood glucose results were not provided.
 
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Brand Name
ACCU-CHEK FLEXLINK INFUSION SET
Type of Device
SUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
UNOMEDICAL DEVICES S.A. DE C.V
avenida fomento industrial lot
parque industrial del norte
reynosa C.P. 8873
MX   C.P. 88736
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key11656358
MDR Text Key245126294
Report Number3011393376-2021-01191
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Treatment
UNKNOWN INSULIN
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age32 YR
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