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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED TRANSMITTER SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED TRANSMITTER SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-XXX
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091)
Event Date 01/01/2015
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: 2032227-2015-40032.
 
Event Description
The customer reported via phone call that she experienced skin irritation and infection from the infusion sets and sensors and had to be hospitalized at the end of (b)(6) with diabetic ketoacidosis. The customer stated that the first time was around (b)(6) 2015 and it got worse on (b)(6). The customer stated she experienced high blood glucose and the site showed signs of infection; her skin color was white and greenish and it had swelling. Infusion set area was at the arm and sensor at the abdomen. The customer stated she could only use the infusion set for one and a half days and the sensor for 3 or 4 days before the skin becomes irritated. The transmitter was also used in conjunction with the sensor. She stopped using the insulin pump about a week prior to the hospitalization due to the skin infection. Customer was advised to contact her doctor for options. The product will not be returned for analysis.
 
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Brand NameTRANSMITTER
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 Key6765621
MDR Text Key81780187
Report Number2032227-2017-34040
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-XXX
Device Catalogue NumberMMT-XXX
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 Received08/15/2015
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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