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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S SURE-T PARADIGM CONTACT DETACH

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UNOMEDICAL A/S SURE-T PARADIGM CONTACT DETACH Back to Search Results
Model Number MMT-864
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypoglycemia (1912); Brain Injury (2219); Coma (2417)
Event Type  Injury  
Manufacturer Narrative
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). Event country (b)(6). In (b)(6) 2017 a female diabetic patient experienced hypoglycemia and was found 16 hours later unconscious. Patients husband reported multiple suspensions and resumes of basal, based on the pump history. Patient is currently in the hospital in a diabetic coma with severe brain injury. At reporting time it was her third week in princess alexandra hospital in brisbane. Patient was not claiming any set malfunctions. No further information provided.
 
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Brand NameSURE-T PARADIGM
Type of DeviceCONTACT DETACH
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 Key6978947
MDR Text Key90288471
Report Number3003442380-2017-00015
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 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-864
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 Received09/15/2017
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: 10/26/2017 Patient Sequence Number: 1
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