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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC BLUE
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MIO¿; INSET II 80/6 PCC BLUE Back to Search Results
Lot Number 5170785
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
(b)(4).Event occurred in the united states.The patient's father reported that they had issues with a couple of infusion sets as they did not deliver insulin.Reportedly, his son's blood glucose was 499 mg/dl at the time of first event and 522 mg/dl at the time of second event.They stopped the pump and he gave him a manual injection and changed the site twice.Subsequently, the patient was hospitalized when his high blood glucose level was in 500 mg/dl and he experienced diabetic ketoacidosis.Moreover, his stomach was hurting which doubled up the pain.He was admitted for two days.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 80/6 PCC BLUE
MDR Report Key8517108
Report Number3003442380-2019-01164
Device Sequence Number1473985
Product Code FPA
UDI-Device Identifier05705244007734
UDI-Public05705244007734
Combination Product (Y/N)N
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Lot Number5170785
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/29/2017
Initial Report FDA Received Date04/16/2019
Patient Sequence Number1
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