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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC MINI-MED 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

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MEDTRONIC MINIMED MEDTRONIC MINI-MED 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number MINI-MED 630G
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Hypoglycemia (1912); Overdose (1988)
Event Date 02/01/2019
Event Type  Injury  
Event Description

I used a medtronic mini-med 630g. Woke up about 2 am with low that went from bad to worse. Spent 2 hrs at home trying everything possible to get bs numbers up after eating 3000 calories and consuming a gallon of pure sugar liquid, i couldn't get above 45 on my tests and then i kept dropping into the 30's and so low it wouldn't even register. Went to the er about 4:30 am. Was hooked up to an iv and given several bags of glucose. Got moved to icu where i stayed until the evening when my numbers finally started going up. The only explanation was that the pump malfunctioned and i got an overdose of insulin. Fda safety report id# (b)(4).

 
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Brand NameMEDTRONIC MINI-MED 630G
Type of DeviceAUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key9799645
MDR Text Key182547503
Report NumberMW5093551
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
Type of Report Initial
Report Date 03/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMINI-MED 630G
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/05/2020 Patient Sequence Number: 1
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