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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED XMTR MMT-7811NA GST3C LOCKOUT SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED XMTR MMT-7811NA GST3C LOCKOUT SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7811NA
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Skin Irritation (2076); Discomfort (2330); Skin Inflammation (2443)
Event Date 10/11/2017
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¿s father reported via phone call that the customer experienced skin irritation at the sensor site. He indicated that the area was extremely raw, with scratches, bleeding and pain. The customer went to their healthcare provider¿s office and the doctor recommended new site locations and provided sample products to assist with irritation. The patient's blood glucose value was 120 mg/dl. The sensor and transmitter will not be returned for analysis.
 
Manufacturer Narrative
The event was reported in error.
 
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Brand NameXMTR MMT-7811NA GST3C LOCKOUT
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 Key7589581
MDR Text Key110702757
Report Number2032227-2018-05056
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-7811NA
Device Catalogue NumberMMT-7811NA
Device Lot NumberA000389279
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/11/2018 Patient Sequence Number: 1
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