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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 Insufficient Information (3190)
Patient Problems Hypoglycemia (1912); Brain Injury (2219)
Event Date 05/27/2017
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). In (b)(6) 2017 a female diabetic patient on pump therapy experienced a low blood glucose level event during the night and had a hypoglycemic seizure and never recovered. Doctor told husband that his wifes brain had suffered extreme lack of oxygen. Blood glucose level was 31 mg/dl at the time the emt's arrived. Patients health had been declining rapidly over the last few months and she was also diagnosed with gastroparesis, adrenal gland attrified and kidney failure. Patient was admitted to the hospital due to the event. The infusion pump and infusion set was removed at that time and was never re-connected again. Patient died at the hospital on (b)(6) 2017 as a consequence of the medical history. No further information provided at this time.
 
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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
548167000
MDR Report Key7198785
MDR Text Key97475566
Report Number3003442380-2018-00004
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 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
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?
Event Location No Information
Date Manufacturer Received12/26/2017
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: 01/17/2018 Patient Sequence Number: 1
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