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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 80/6 PCC MIMX
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SURE-T PARADIGM; UNO CONTACT DETACH G29 80/6 PCC MIMX Back to Search Results
Model Number MMT-866
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states the patient reported that patient's infusion set's tubing became disconnected on the quick release, while she was sleeping.Further, she does not know if it got pulled out as she woke up and saw that the tubing was out.The site location was on left side of her abdomen and the pump was placed on the bed next to her when she is sleeping.The infusion had been used for at least 24 - 48 hrs.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, her blood glucose level was 120 mg/dl.No further information available.
 
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Brand Name
SURE-T PARADIGM
Common Device Name
UNO CONTACT DETACH G29 80/6 PCC MIMX
MDR Report Key10972974
Report Number3003442380-2020-00468
Device Sequence Number791077
Product Code FPA
UDI-Device Identifier05705244006058
UDI-Public05705244006058
Combination Product (Y/N)Y
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
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 Date01/01/2023
Device Model NumberMMT-866
Device Lot Number5306113
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/25/2020
Initial Report FDA Received Date12/08/2020
Patient Sequence Number1
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