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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURE-T PARADIGM UNO CONTACT DETACH G29 60/6 SC1 MIMX

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SURE-T PARADIGM UNO CONTACT DETACH G29 60/6 SC1 MIMX Back to Search Results
Model Number MMT-864A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. It was reported that a female child patient experienced hyperglycemia (blood glucose level at the time of incident was 587 mg/dl) and ketone level due to her infusion set failure. Therefore, she changed her infusion set and took a manual injection, but her blood glucose level remained in the 400-500's into the early hours. The patient again changed her set and took another manual injection. Further, her blood glucose and ketone levels normalized after several hours. No further information available.
 
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Brand NameSURE-T PARADIGM
Type of DeviceUNO CONTACT DETACH G29 60/6 SC1 MIMX
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key11283934
MDR Text Key230456048
Report Number3003442380-2021-00135
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-864A
Device Lot Number5317622
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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