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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 Material Twisted/Bent (2981); Physical Resistance/Sticking (4012); Activation Problem (4042)
Patient Problem Hyperglycemia (1905)
Event Date 02/27/2022
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.
 
Event Description
It was reported that customer was experienced high blood glucose. Blood glucose level at the time of the incident was 510 mg/dl and current blood glucose was 338 mg/dl and user reported inaccurate sensor readings that triggered a threshold suspend. The customer¿s blood glucose was 510 mg/dl and sensor glucose was 40 mg/dl at the time of the event, the difference is outside the acceptable range. The customer stated that there was no symptoms related to high blood glucose. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Insulin pump passed self test. The customer will continue use of the device.
 
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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
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
tricha miles
18000 devonshire st.
northridge, CA 91325
7635140379
MDR Report Key13692109
MDR Text Key286842835
Report Number2032227-2022-121686
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/12/2022
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Device Lot NumberJ1421P
Was Device Available for Evaluation? No
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/08/2022 Patient Sequence Number: 1
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