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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008A
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Device Displays Incorrect Message (2591)
Patient Problems Bruise/Contusion (1754); Pain (1994); Scarring (2061); Skin Irritation (2076)
Event Date 09/10/2017
Event Type  malfunction  
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 reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s blood glucose was 200 mg/dl and the sensor glucose was going down to 40 mg/dl. The customer also stated her sensor her was going down to 60 mg/dl which suspend her delivery. The customer stated that sensor caused pain with bruising and hole in skin causing scar. Troubleshooting was performed and customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. The sensor will not be returned for analysis.
 
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Brand NameSENSOR ENLITE MMT-7008A
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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 Key6880538
MDR Text Key87792723
Report Number2032227-2017-50703
Device Sequence Number1
Product Code OZO
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 09/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
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 Received09/11/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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