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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 80/8 PCC
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SURE-T® PARADIGM®; CONTACT DETACH G29 80/8 PCC Back to Search Results
Lot Number 5215330
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 the infusion set fell off while the patient was using it on her leg.The blood glucose level was 300-400 mg/dl and the site location was at the upper abdomen.No further information available.
 
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Brand Name
SURE-T® PARADIGM®
Common Device Name
CONTACT DETACH G29 80/8 PCC
MDR Report Key8502784
Report Number3003442380-2019-01043
Device Sequence Number13508563
Product Code FPA
UDI-Device Identifier05705244006072
UDI-Public05705244006072
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 Number5215330
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/18/2018
Initial Report FDA Received Date04/11/2019
Patient Sequence Number1
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