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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 Problem Failure To Adhere Or Bond (1031)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091); Blood Loss (2597)
Event Date 08/22/2016
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. Reference manufacturer report number: 2032227-2016-23242.
 
Event Description
Customer reported via phone call to have gotten an abscess on her arm the size of a nickel due to sensor. Customer reported that the site was cleaned properly prior to insertion. Customer visited healthcare professional who had to cut abscess and drain it. Customer's blood glucose was unknown. The transmitter was also used in conjunction with the sensor. Customer also reported that tape was not sticking correctly. Customer stated that healthcare professional advise to wear sensor in the arm. Customer was advised to speak with healthcare professional regarding alternate sites and irritation. 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 Key6765572
MDR Text Key81779589
Report Number2032227-2017-34022
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
Report Date 08/03/2017
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 NumberA000365138
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 Received09/01/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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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