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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 Problem Hypoglycemia (1912)
Event Date 08/13/2017
Event Type  Injury  
Manufacturer Narrative
Event was reported in error. 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.
 
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 called to report a low blood glucose level of 47 mg/dl. The customer treated the low blood glucose level with juice. The customer stated the blood glucose level is now 60 mg/dl. The customer declined to troubleshoot for the low blood glucose level. 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 Key6839787
MDR Text Key187999541
Report Number2032227-2017-44073
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,Followup
Report Date 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2017
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 NumberA000341647
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 Received04/20/2020
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: 09/01/2017 Patient Sequence Number: 1
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