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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INSULIN PUMP SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED INSULIN PUMP SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 551
Device Problem Device Inoperable (1663)
Patient Problems Hyperglycemia (1905); Vomiting (2144)
Event Date 04/01/2018
Event Type  Injury  
Event Description
I use a medtronic insulin pump. On sunday (b)(6) 2017 this pump malfunctioned causing my blood sugar levels to soar resulting in vomiting and hospitalization. In addition, the transmitter to my sensor died. I called medtronic on monday morning, after switching to a much older spare pump that is not as efficient. My calls to the pump order support went unanswered. I finally was able to reach the contact for (b)(6) to make arrangements for a replacement pump and sensor transmitter. He told me he would have to complete the paperwork and send to my doctor's office and this would take a few days. A few days? you are talking about my pancreas! calls are unanswered. Supplies are on back order so you have a (b)(6) pump that you can't get supplies for. When you have diabetes tight control is critical and medtronic is not enabling patients to maintain this control. They have a monopoly. Insurance only covers a pump every 4 years so it's not as though you can try another brand. Please, please, please, help the tens of thousands of patients with diabetes maintain good control. Can you somehow work with, encourage medtronic to actually meet patient needs? how would they feel if the fda didn't return their calls when they submit a product for 510 approval? since using the older pump i am not able to have control over my blood sugar levels. Continue to spike over 300 on a regular basis. I need a pump and i need it now. And unfortunately this giant corporation doesn't care about my health. Diagnosis or reason for use: diabetes. Event abated after use stopped or dose reduced: no.
 
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Brand NameINSULIN PUMP
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key7411251
MDR Text Key105251411
Report NumberMW5076380
Device Sequence Number1
Product Code MDS
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 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number551
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: 04/09/2018 Patient Sequence Number: 1
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