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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)
Event Date 08/09/2017
Event Type  Death  
Manufacturer Narrative
Date: 12/12/2017. 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). Fda reference number mw5072865. In (b)(6) 2017 a male diabetic patients insulin infusion device failed and he died of hypoglycemia. 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 Key7107714
MDR Text Key94490078
Report Number3003442380-2017-00027
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 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
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 Received11/16/2017
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: 12/12/2017 Patient Sequence Number: 1
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