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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET, INFUSION SET

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UNOMEDICAL A/S QUICK-SET, INFUSION SET Back to Search Results
Model Number MMT-387
Device Problem Material Twisted/Bent (2981)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
The claimed failure cannot be confirmed. No lot number reported and no device returned for investigation.
 
Event Description
Unomedical reference number: (b)(4). Wife reported that male diabetic patient on pump therapy has passed away. Reported infusion set tubing kinked and his blood sugars went to over 1000 mg/dl by the time he they got to hospital he was in dka and passed away shortly after. Date of hospitalization and death unknown. No further information available.
 
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Brand NameQUICK-SET, INFUSION SET
Type of DeviceQUICK-SET
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key9102726
MDR Text Key159569082
Report Number3003442380-2019-00007
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991759
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-387
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/23/2019 Patient Sequence Number: 1
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