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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S MEDTRONIC INFUSION SET QUICK-SET PARADIGM INSULIN INFUSION SET Back to Search Results
Model Number MMT-397
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Hypoglycemia (1912)
Event Date 09/17/2017
Event Type  Death  
Manufacturer Narrative
Together with medtronic unomedical is still trying to obtain further information and, possibly, also to obtain the infusion set used at time of the primary incident. If new, relevant information becomes available, we will reopen the case and act appropriately, including providing a follow-up report to fda. It is however increasing likely that we will not be able to more information.
 
Event Description
(b)(4). Note: this case involves (b)(6) citizen and occurs in the (b)(6). A female diabetic patient is receiving insulin via a medtronic insulin pump and a medtronic quick-set infusion set. The (b)(6) reports some details from a 'user report' including that on (b)(6) 2017 a 'suspected faulty' infusion set allegedly may have delivered excessive insulin resulting in hypoglycemia, brain damage and lastly, on (b)(6) 2017, death. Even after initial medtronic local investigations in (b)(6), there is confusion on many details, including pump (and infusion set) location(s). A (b)(6) coroner refer to two different hospitals - who both refer back to the coroner. Medtronic staff is continuing in their efforts to provide further information. Analysis of the pump's internal memory could provide important data. Likewise, investigation of the infusion set used at time of the primary incident on (b)(6) 2017 may provide important data. Infusion set lot number: not known exactly, but probably one of: (b)(4).
 
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Brand NameMEDTRONIC INFUSION SET QUICK-SET PARADIGM
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 Key7240420
MDR Text Key98972834
Report Number3003442380-2018-00009
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 02/05/2018
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 NumberMMT-397
Device Lot NumberSEE NARRATIVE DESCR.
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 Received11/23/2017
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: 02/05/2018 Patient Sequence Number: 1
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