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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 5326845
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 09/05/2021
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
On (b)(6) 2021 in the night, the patient was hospitalized with hyperglycemia and ketoacidosis and was vomiting.In the hospital, the pump was removed, the patient was given intravenous insulin and therapy was started according to the hospital protocol (dipyrone administered + drops of potassium and regular insulin).The father explained that they had missed the deadline for changing the cannula (3 days).The patient was discharged from the hospital on (b)(6) 2021.The blood glucose was normalized and the pump was reinstalled.
 
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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
MDR Report Key12518256
MDR Text Key272866959
Report Number3011393376-2021-02947
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/01/2022
Device Lot Number5326845
Was Device Available for Evaluation? No
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Treatment
UNKNWON INSULIN
Patient Outcome(s) Hospitalization;
Patient Age4 YR
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