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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 30; INSET 30 60/13 GREY TCAP
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AUTOSOFT 30; INSET 30 60/13 GREY TCAP Back to Search Results
Lot Number 5245330
Device Problem Material Twisted/Bent (2981)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
(b)(4).Event occurred in the united states.The patient stated issues with infusion set in the form of bent cannulas with blood glucose level of up to 380 mg/dl.Subsequently, she was taken to emergency room (er) as she was not feeling well.At that time, her blood glucose level was 180 mg/dl and had large ketones as well.She was in emergency room for 3 hours and received intravenous fluids and correction boluses with pump as corrective treatment.She was still not feeling well when left the er.She was finally hospitalized after receiving the treatment for high blood glucose (up to 200 mg/dl) and ketones.Her ketones were levels were assessed as dangerous and life threatening.Reportedly, the patient was using infusion set for two days.The patient was hospitalized for two days.After getting discharged, she changed the site and noticed that the cannula was bent.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
AUTOSOFT 30
Type of Device
INSET 30 60/13 GREY TCAP
Manufacturer Contact
aaholmvej 1-3
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MDR Report Key8195210
MDR Text Key131373830
Report Number3003442380-2018-00164
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244014602
UDI-Public05705244014602
Combination Product (y/n)N
PMA/PMN Number
K061374
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
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date01/07/2021
Device Lot Number5245330
Date Manufacturer Received11/28/2018
Type of Device Usage N
Patient Sequence Number1
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