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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S INFUSION SET UNKNOWN

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UNOMEDICAL A/S INFUSION SET UNKNOWN Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Hypoglycemia (1912); Brain Injury (2219)
Event Date 12/17/2017
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
(b)(4). On (b)(6) 2017 a male diabetic patient on pump therapy experienced a low blood glucose level event. Patient's blood glucose level decreased to 20 mg/dl and patient went in a hypoglycemic coma and suffered brain seizures. It is unknown how long he was in this state prior to being found. Wife is unaware of what actually caused his bg to drop but believes that at 4am he went to bed and usually takes off the pump but that evening he did not. Patient was admitted to the hospital they were trying to give him glucose to keep his blood sugar up but they couldn't it would just continue to drop and then on tuesday (b)(6) 2017 bg started to rise and they made the bg go up to 300 and then would bring it down slowly. A week later patient died of natural causes. No further information provided.
 
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Brand NameINFUSION SET UNKNOWN
Type of DeviceINFUSION SET UNKNOWN
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 Key7233578
MDR Text Key98757214
Report Number3003442380-2018-00007
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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?
Event Location No Information
Date Manufacturer Received01/11/2018
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: 02/01/2018 Patient Sequence Number: 1
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