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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 Problems Fluid Leak (1250); Material Twisted/Bent (2981)
Patient Problems Dehydration (1807); Hyperglycemia (1905); Vomiting (2144)
Event Date 01/11/2021
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. Product no longer available for return.
 
Event Description
It was reported that the infusion set on the headset was leaking. The patient reported that on the day of the event she went to school to take an exam. When she arrived at school, she noticed that the adhesive of the plaster was wet. In addition, the cannula was kinked, resulting in under-delivery of insulin and high blood glucose levels. The patient's skin was hurt by the folded cannula. She had a blood glucose level of hi mg/dl (> 600 mg/dl) and was treated by the school doctor who gave her 10 units of insulin (humalog regular insulin). After a few hours, the blood glucose level decreased to 400 mg/dl. During the exam, her blood glucose, oxygen level and blood pressure were checked regularly by the school nurse. The patient had symptoms of vomiting, polydipsia and polyuria. After finishing the exam, she went back home, changed the cannula and her blood glucose level stabilized.
 
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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
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key11313134
MDR Text Key231317598
Report Number3011393376-2021-00477
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
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeNULL
Event Location No Information
Date Manufacturer Received01/27/2021
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: 02/11/2021 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
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