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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 Break (1069); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
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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 Key13529676
Report Number2032227-2022-113153
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeFR
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 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/10/2022
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Device Lot NumberG1421P
Was Device Available for Evaluation? No
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/14/2021
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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