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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S SURE T

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UNOMEDICAL A/S SURE T Back to Search Results
Model Number MMT-864
Device Problem Fluid Leak (1250)
Patient Problem Coma (2417)
Event Type  Injury  
Manufacturer Narrative
The reference samples were visually inspected and tested for flow and leak. And all were found within specifications. The batch record #: (b)(4) was verified and found it within specifications. The claim failure cannot be confirmed. An investigation has been performed based on the customer complaint description and the reference sample from the same number. According to unomedical traceability record, no relevant deviation were found. If new information become available, the complaint will be re-opened and appropriate action will be taken.
 
Event Description
Unomedical reference number: (b)(4). A diabetic female patient reported that the infusion set was leaking on site and not delivering insulin and she went into a coma and was hospitalized. Patient had leaks in her site, especially when she does a bolus. Patient stated that there was not any stress or pull on the infusion set tubing. Patient was able to change the infusion set. Therapy at hospital is unknown. Date of incident is unknown. No further information is available.
 
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Brand NameSURE T
Type of DeviceSURE T
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICA A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key11121616
MDR Text Key225290172
Report Number3003442380-2021-00001
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-864
Device Lot Number5285757
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/05/2021 Patient Sequence Number: 1
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