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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INSULIN PUMP MINI 600 SERIES; AUTOMATED INSULIN DOSING , THRESHOL
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MEDTRONIC MINIMED INSULIN PUMP MINI 600 SERIES; AUTOMATED INSULIN DOSING , THRESHOL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Fall (1848); Bone Fracture(s) (1870); Loss of consciousness (2418)
Event Date 01/18/2020
Event Type  Death  
Event Description
My mother was using this insulin pump.She was preparing for knee surgery on tuesday (following her death), and had seen every doctor to be cleared.She was in her best health in years.She was home alone that morning and passed out on the toilet, fell and broke her neck / cut off her airway.Her sugar was in the 70's the evening before.We were unaware of this recall until a week after she was cremated.So we don't have any way to know what caused her to pass out or how low her sugar was.The medics said they were ruling it natural causes and if we wanted to get an autopsy we would have to pay $5000 out of our pocket up front.We chose not to.Fda safety report id# (b)(4).
 
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Brand Name
INSULIN PUMP MINI 600 SERIES
Type of Device
AUTOMATED INSULIN DOSING , THRESHOL
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key10055594
MDR Text Key191102665
Report NumberMW5094479
Device Sequence Number1
Product Code OZO
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 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/13/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age68 YR
Patient Weight82
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