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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED TRANSMITTER MMT-7731 GST3B REPLACEMENT SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED TRANSMITTER MMT-7731 GST3B REPLACEMENT SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7731
Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2017
Event Type  malfunction  
Manufacturer Narrative
The event was reported in error.
 
Manufacturer Narrative
The follow up report was submitted with blank. The correct date is 15-apr-2020.
 
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 multiple sensor signal not found alarms and the insulin pump had a display was black. The customer¿s blood glucose level was unknown at the time of the incident. The customer was assisted with troubleshooting. The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan. The insulin pump will not be returned for analysis.
 
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Brand NameTRANSMITTER MMT-7731 GST3B REPLACEMENT
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 Key6870000
MDR Text Key187838312
Report Number2032227-2017-48683
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7731
Device Catalogue NumberMMT-7731
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 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

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