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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 11/06/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, the patient was hospitalized with hyperglycemia and ketoacidosis and was vomiting. In the hospital, the patient stayed with the pump for insulin administration. She stayed on a drop and had blood gas exams performed. The physician reported that the cannula was not changed every 2 days as instructed; the insertion site was the same as the last and the cannula was also not changed within the correct period because it seemed to be worn and changed in color. On (b)(6) 2021, the patient´s father changed the insertion site of the cannula and the patient´s blood glucose level improved significantly. No information on the discharge of the patient from the hospital.
 
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. No product will be returned for evaluation.
 
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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 Key12853825
MDR Text Key281097459
Report Number3011393376-2021-03648
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 Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2022
Device Lot Number5326845
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 11/22/2021 Patient Sequence Number: 1
Treatment
LIBRE SENSOR; SOMENTE SORO
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