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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; UNO INSET II 80/9 PCC GREY MIMX
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UNOMEDICAL A/S MIO; UNO INSET II 80/9 PCC GREY MIMX Back to Search Results
Model Number MMT-975
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/16/2024
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient city: (b)(6).
 
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in italy it was reported that the patient faced an insulin flow block alarm and insulin did not exit tubing during priming.No further information available.
 
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Brand Name
MIO
Common Device Name
UNO INSET II 80/9 PCC GREY MIMX
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA  4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key19786639
Report Number3003442380-2024-15511
Device Sequence Number8181302
Product Code FPA
UDI-Device Identifier05705244007833
UDI-Public05705244007833
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/20/2024
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 Lay User/Patient
Device Model NumberMMT-975
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/20/2024
Initial Report FDA Received Date07/20/2024
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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