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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/6 GREY
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T:90¿ INFUSION SET; INSET II 60/6 GREY Back to Search Results
Lot Number 5183288
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Hyperglycemia (1905)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The was reported, that while sleeping, the patient's infusion set came apart at the connector.The blood glucose, at the time of this event was 296 mg/dl.There was no damage reported when the package was first opened.No further information available.
 
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Brand Name
T:90¿ INFUSION SET
Common Device Name
INSET II 60/6 GREY
MDR Report Key8494327
Report Number3003442380-2019-00938
Device Sequence Number16559946
Product Code FPA
UDI-Device Identifier05705244004412
UDI-Public05705244004412
Combination Product (Y/N)N
PMA/510(K) Number
K032854
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? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Lot Number5183288
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/11/2018
Initial Report FDA Received Date04/09/2019
Patient Sequence Number1
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