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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 80/10 PCC
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SURE-T® PARADIGM®; CONTACT DETACH G29 80/10 PCC Back to Search Results
Lot Number 5210008
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that when the patient woke up, found out that tubing was detached from the quick release and had high blood glucose level.The site was at the left abdomen and the pump was just beside the patent on bed.The infusion set had been in use for the second day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.In the investigation it was found that the glue was missing from the tubing connector (glue was misplaced on the tubing connector).No further information available.
 
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Brand Name
SURE-T® PARADIGM®
Common Device Name
CONTACT DETACH G29 80/10 PCC
MDR Report Key8534846
Report Number3003442380-2019-01265
Device Sequence Number2457809
Product Code FPA
UDI-Device Identifier05705244006034
UDI-Public05705244006034
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? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Lot Number5210008
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/05/2018
Initial Report FDA Received Date04/22/2019
Patient Sequence Number1
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