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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 NameACCU-CHEK FLEXLINK INFUSION SET
Type of DeviceSUBCUTANEOUS 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
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key12518256
MDR Text Key272866959
Report Number3011393376-2021-02947
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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
Device Lot Number5326845
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 09/23/2021 Patient Sequence Number: 1
Treatment
UNKNWON INSULIN
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