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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S SURE T PARADIGM CONTACT DETACH PCC Back to Search Results
Model Number MMT-864
Device Problems Low Test Results (2458); Insufficient Information (3190)
Patient Problems Hypoglycemia (1912); Convulsion, Clonic (2222); Loss of consciousness (2418)
Event Date 02/28/2017
Event Type  Injury  
Manufacturer Narrative
02/05/2018. Incident happened in (b)(6). The reference samples were visually inspected and tested for flow and leak and ventilation. All test results were within specifications. The batch record # 5158839 was verified and found it within specifications. Based on the investigation and test results the claimed failure can not be confirmed. If new information becomes available the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). Incident occurred in (b)(6). On (b)(6) 2017 a male diabetic patient on pump therapy experienced a low blood glucose level event during the evening, which resulted in a hypoglycemic event and the patient experienced convulsions and lost consciousness. Patient was admitted to hospital (b)(6). Patients mother mentioned that her son had been hospitalized for twenty days due to hypoglycemia. No further information provided.
 
Manufacturer Narrative
(b)(6). Unomedical is still pending information about this event, therefore no testing has been performed at this time. A follow-up report will be sent no later than 02/09/2018.
 
Event Description
(b)(4). Incident occurred in (b)(6). On (b)(6) 2017 a male diabetic patient on pump therapy experienced a low blood glucose level event during the evening, which resulted in a hypoglycemic event and the patient experienced convulsions and lost consciousness. Patient was admitted to hospital (b)(6) in (b)(6). Patients mother mentioned that her son had been hospitalized for twenty days due to hypoglycemia. No further information provided at this time.
 
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Brand NameSURE T PARADIGM
Type of DeviceCONTACT DETACH PCC
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
MDR Report Key7199030
MDR Text Key280747326
Report Number3003442380-2018-00005
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
Type of Report Initial,Followup
Report Date 02/05/2018
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 Expiration Date08/01/2021
Device Model NumberMMT-864
Device Lot Number5158839
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/17/2018 Patient Sequence Number: 1
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