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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET PARADIGM QUICK-SET PCC

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UNOMEDICAL A/S QUICK-SET PARADIGM QUICK-SET PCC Back to Search Results
Model Number MMT-397
Device Problem Connection Problem (2900)
Patient Problems Death (1802); Diabetic Ketoacidosis (2364)
Event Date 04/23/2018
Event Type  Death  
Manufacturer Narrative
The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description and the reference samples from the same lot number. According to unomedical's traceability records, no relevant deviations were found. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
Unomedical reference number (b)(4). On (b)(6) 2018 a male diabetic patient on pump therapy passed away due to diabetic ketoacidosis and coma. In the morning, patient woke up with a blood glucose level above 600 mg/dl and was vomiting. When patient went with the ems, the pump was still connected to the patient and they removed the pump. At that time, they noticed that the tubing that come out at the end, it was broken. Patient had a blood glucose above 1500 mg/dl when he died. No further information provided.
 
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Brand NameQUICK-SET PARADIGM
Type of DeviceQUICK-SET PCC
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 Key7581427
MDR Text Key110448719
Report Number3003442380-2018-00023
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-397
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2017
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: 06/08/2018 Patient Sequence Number: 1
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