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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC QUICK-SET PARADIGM INFUSION SET INSULIN INFUSION SET

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UNOMEDICAL A/S MEDTRONIC QUICK-SET PARADIGM INFUSION SET INSULIN INFUSION SET Back to Search Results
Model Number MMT-397
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Hyperglycemia (1905)
Event Date 11/18/2019
Event Type  Death  
Manufacturer Narrative
Lot 5154294. Reference samples have been analysed without any findings of malfunctions. A batch review has been conducted: all within specifications.
 
Event Description
Unomedical reference (b)(4) (medtronic ref svn (b)(4)). On 25-nov-2019 medtronic informs unomedical about a legal, fatal case. A (b)(6) year old female diabetic patient is treated with insulin via a medtronic insulin pump and a quick-set insulin infusion set, model mmt-397, manufactured by unomedical. A lawyer alleges that she died on (b)(6) 2019 following an overdose of insulin caused by infusion set vent block membrane failure. The overdose allegedly led to severe hypoglycemia which was not treated and thus ultimately led to the death of the patient. Note: the fatal incident occurred some 2 months after medtronic and unomedical launched a voluntary recall of the potentially affected infusion set products on 11-sep-2017. Recall references are unomedical: ma-2017-02; medtronic: fa-784. At the moment we do not have further facts on the fatal incident. Due to the scarce information available unomedical cannot presently make any reasonable assessment of possible causal relation between the fatal incident and the used infusion set.
 
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Brand NameMEDTRONIC QUICK-SET PARADIGM INFUSION SET
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 Key9478955
MDR Text Key171562541
Report Number3003442380-2019-00008
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K106648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2019
Device Model NumberMMT-397
Device Lot Number5154294
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
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: 12/17/2019 Patient Sequence Number: 1
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