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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC INSULIN PUMP; PUMP, INFUSION, INSULIN
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MEDTRONIC, INC. MEDTRONIC INSULIN PUMP; PUMP, INFUSION, INSULIN Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malaise (2359)
Event Date 10/17/2021
Event Type  Death  
Event Description
My dad had complained the day before to family, whom he had dinner with, of not feeling well.It appeared to have been a blood sugar problem.They were concerned about him so his cousin called him the next day around noon and asked how he was and he said "great!".It was not like him to answer in that manner.That tells me that his blood sugar was off at that time, but his cousin did not recognize that.That afternoon he went for a short swim like he did every day.When he was late for dinner, his cousin's husband went over to check on him and found him deceased in the pool.Fda safety report id # (b)(4).
 
Event Description
My dad had complained the day before to family, whom he had dinner with, of not feeling well.It appeared to have been a blood sugar problem.They were concerned about him so his cousin called him the next day around noon and asked how he was and he said "great!".It was not like him to answer in that manner.That tells me that his blood sugar was off at that time, but his cousin did not recognize that.That afternoon he went for a short swim like he did every day.When he was late for dinner, his cousin's husband went over to check on him and found him deceased in the pool.Fda safety report id # (b)(4).
 
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Brand Name
MEDTRONIC INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key13591823
MDR Text Key286127359
Report NumberMW5107650
Device Sequence Number1
Product Code LZG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age77 YR
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceWhite
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