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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 Break (1069); Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hyperglycemia (1905); Unspecified Infection (1930); Diabetic Ketoacidosis (2364); Coma (2417)
Event Date 04/23/2018
Event Type  Death  
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
It was reported that the customer passed away in hospital. The customer was hospitalized on (b)(6) 2018 due to high blood glucose, diabetic ketoacidosis, and a coma. The cause of death was a coma and diabetic ketoacidosis. The caller stated that the customer had no illnesses that may have led to the customer's passing. The customers blood glucose was over 1500 mg/dl at the time of admission. The customer was not wearing the insulin pump at the time of death. The pump had been removed within less than 48 hours prior to passing, as the paramedics took off the pump. The customer was using sensors. The caller also reported that the customer had a high of over 600 on (b)(6) 2018 and they woke up vomiting, and later that day they noticed that the tubing that came out was broken and really loose like it had been cut. The caller declined to return the insulin pump for analysis or to upload the pump.
 
Manufacturer Narrative
The event was reported in error.
 
Manufacturer Narrative
The initial report was created in error as it was previously reported under mdr number 3004209178-2018-77974.
 
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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 Key7584958
MDR Text Key110569824
Report Number2032227-2018-04849
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 other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberMMT-7703NA
Device Catalogue NumberMMT-7703NA
Device Lot NumberA000330545
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 Received12/10/2020
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: 06/08/2018 Patient Sequence Number: 1
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