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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MINILINK TRANSMITTER MMT-7703NA SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED MINILINK TRANSMITTER MMT-7703NA SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7703NA
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Pain (1994); Skin Irritation (2076); Blood Loss (2597)
Event Date 06/26/2017
Event Type  malfunction  
Manufacturer Narrative
The event was reported in error.
 
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. Reference manufacturer report number: 2032227-2017-30464.
 
Event Description
The customer reported via phone call that their site began burning, bleeding, and bruising after 4 days of wearing the sensor. The customer¿s blood glucose level was unknown. Troubleshooting was not performed. The customer also used the transmitter along with the sensor. The product will not be returned for analysis.
 
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Brand NameMINILINK TRANSMITTER MMT-7703NA
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 Key6765936
MDR Text Key188174540
Report Number2032227-2017-34118
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,Followup
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-7703NA
Device Catalogue NumberMMT-7703NA
Device Lot NumberA000344716
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 Received04/17/2020
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: 08/03/2017 Patient Sequence Number: 1
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