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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED STARTER KIT MMT-7730 TRANSMITTER GST3 SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED STARTER KIT MMT-7730 TRANSMITTER GST3 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7730
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Hypoglycemia (1912)
Event Date 01/29/2019
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. 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
It was reported that they experienced low blood glucose level. The customer¿s blood glucose was 46 mg/dl. The device will be returned for analysis.
 
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Brand NameSTARTER KIT MMT-7730 TRANSMITTER GST3
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 Key8377379
MDR Text Key137366777
Report Number2032227-2019-01821
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeMX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-7730
Device Catalogue NumberMMT-7730
Device Lot NumberW000493525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/18/2018
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: 02/28/2019 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET.
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