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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 5209625
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 (b)(6).The patient reported that, the infusion set got loose at site of quick release.The patient did not notice until blood glucose level was 22 mmol/l last.No further information available.
 
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Brand Name
SURE-T® PARADIGM®
Common Device Name
CONTACT DETACH G29 80/10 PCC
MDR Report Key8265880
Report Number3003442380-2019-00247
Device Sequence Number14046017
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 Expiration Date10/01/2020
Device Lot Number5209625
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/02/2018
Initial Report FDA Received Date01/21/2019
Patient Sequence Number1
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