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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 Calibration Problem (2890)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/30/2020
Event Type  malfunction  
Manufacturer Narrative
Device was able to charge, communicated and sync properly during radio frequency association. However, device failed accuracy test with isig values out of range; problem was isolated to electronic assembly.
 
Manufacturer Narrative
(b)(4). Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
Information received by medtronic the user reported inaccurate sensor readings that triggered a threshold suspend. The customer¿s blood glucose was 112 mg/dl and sensor glucose was 41 mg/dl at the time of the event, the difference is outside the acceptable range. Suspend on low limit in sensor settings was at 41 mg/dl. No harm requiring medical intervention was reported. The sensor will not be returned for analysis.
 
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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
8185464805
MDR Report Key10023852
MDR Text Key190886814
Report Number2032227-2020-113221
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
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberMMT-7811NA
Device Catalogue NumberMMT-7811NA
Device Lot NumberA000769495
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/03/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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