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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR GLUCOSE BSA REFRIGERATE MMT-7002B SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED SENSOR GLUCOSE BSA REFRIGERATE MMT-7002B SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7002B
Device Problem Insufficient Information (3190)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 05/05/2018
Event Type  Injury  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
The customer reported via phone call that they were hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2018 with blood glucose of 589 mg/dl. Later the blood glucose value was 82 mg/dl. The customer was treated by intravenous fluids and then with insulin. The sensor will not be returned for analysis.
 
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Brand NameSENSOR GLUCOSE BSA REFRIGERATE MMT-7002B
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire st.
northridge, CA 91325-1219
MDR Report Key7576447
MDR Text Key110323728
Report Number2032227-2018-04585
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 Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-7002B
Device Catalogue NumberMMT-7002B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/06/2018 Patient Sequence Number: 1
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