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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC INSULIN INFUSION SET - UNKNOWN TYPE/MODEL

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UNOMEDICAL A/S MEDTRONIC INSULIN INFUSION SET - UNKNOWN TYPE/MODEL Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Hypoglycemia (1912)
Event Date 11/22/2017
Event Type  Death  
Manufacturer Narrative
There are no allegations from the family that the infusion set contributed to the patient's death. Note: when this case was received by unomedical the initial information was, that the patient had not been using insulin pump therapy for the 22 days leading up to her death at home. Therefore, we at that time considered the death as totally unrelated to the use af any insulin pump infusion set. On 20-jan-2018 we learned that the patient - despite the opposite advise from medtronic helpdesk - had continued to use the old, presumed failing insulin pump. Therefore we have re-evaluated the reportability and are now mdr reporting this fatal incident to fda. We do not expect to receiver further information on this case.
 
Event Description
(b)(4). Medtronic helpdesk is contacted by patient's family (husband and son) informing the their wife/mother passed away on (b)(6) 2017. The patient was waiting to have her failing insulin pump replaced. While waiting, she had been advised not to use her insulin pump until the replacement pump had arrived. After 22 days, however, the patient was found dead at home, on the floor and wearing tho old pump. Pump was removed by her husband. There is no formal cause of death available, but the family states cause to be a very low level of blood glucose (husband states 0 mg/dl). Husband states, that the presumed failing insulin pump caused the death of his wife. It is not known whether the patient's cgm sensor was worn at time of death. Type of medtronic infusion set at time of death is not known. The patient bought her infusion sets and reservoirs from an independent retailer (i. E. Not via a medtronic subscription).
 
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Brand NameMEDTRONIC INSULIN INFUSION SET - UNKNOWN TYPE/MODEL
Type of DeviceINSULIN INFUSION SET
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
MDR Report Key7240302
MDR Text Key98960270
Report Number3003442380-2018-00006
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 Received02/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/05/2018 Patient Sequence Number: 1
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