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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 UNKNOWN
Device Problems Kinked (1339); Infusion or Flow Problem (2964)
Patient Problems Hyperglycemia (1905); Coma (2417)
Event Date 04/20/2018
Event Type  Injury  
Manufacturer Narrative
No relevant testing could be performed. If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints. The claimed failure cannot be confirmed. The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.
 
Event Description
Unomedical reference number (b)(4). On (b)(6) 2018 a male diabetic patient on pump therapy experienced a high blood glucose level event caused by a kinked soft cannula. Patient stated that when he woke up in the morning his blood glucose was over 500 mg/dl. So he went and bought syringes and the blood glucose dropped to around 400 mg/dl. He stated that there was a kink in the cannula and the basal was making it through, but the bolus was not making it at all and his blood glucose raised to over 1000 mg/dl and he was unconscious on the bed at his fathers house and father called ems and spent the next week in (b)(6) hospital. Patient stated that his current set up is not satisfactory and wants to switch over to the sure t infusion set. 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 Key7649501
MDR Text Key112706082
Report Number3003442380-2018-00026
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
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 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
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 Received05/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/29/2018 Patient Sequence Number: 1
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