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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARISOFT UNO COMFORT 110/17 TCAP 10PK INT

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VARISOFT UNO COMFORT 110/17 TCAP 10PK INT Back to Search Results
Model Number 1002832
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Unomedical reference number: (b)(4). Event occurred in the united states. It was reported that on (b)(6) 2022, the patient's infusion set's tubing detached/broken at site connector. This issue occurred with three infusion sets. Reportedly, his blood glucose was 127 mg/dl. The infusion set had been used for one day. Further, they replaced the infusion set and resumed insulin successfully. No further information available.
 
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Brand NameVARISOFT
Type of DeviceUNO COMFORT 110/17 TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key13889733
MDR Text Key288021943
Report Number8021545-2022-00121
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K162812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002832
Device Lot Number5359423
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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