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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC GREY
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MIO¿; INSET II 80/6 PCC GREY Back to Search Results
Lot Number 5234904
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states it was reported that the patient felt nauseous, had difficulty in breathing, chest pain and he faced a bent cannula issue.Patient's blood glucose level was 629 mg/dl at the time of incident.Therefore, on (b)(6) 2019, the patient was admitted to the hospital with blood glucose level of 629 g/dl and diabetic ketoacidosis, where he was treated with insulin drip.At the time of this report ((b)(6) 2019), the patient was still in the hospital.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 80/6 PCC GREY
MDR Report Key9486473
Report Number3003442380-2019-01982
Device Sequence Number14338102
Product Code FPA
UDI-Device Identifier05705244007796
UDI-Public05705244007796
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 Expiration Date04/01/2021
Device Lot Number5234904
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/09/2019
Initial Report FDA Received Date12/18/2019
Patient Sequence Number1
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