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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 Component Missing (2306); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2018
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
It was reported that the sensor had connection issues with the transmitter.The sensor was removed and it had a missing electrode.Blood glucose level at the time of the incident was 150 mg/dl.The customer was advised that the sensor would be replaced.No product is expected to return.
 
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Brand Name
SENSOR ENLITE MMT-7008A
Type of Device
ARTIFICIAL 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
8185464805
MDR Report Key7686796
MDR Text Key114015692
Report Number2032227-2018-08209
Device Sequence Number1
Product Code OZO
UDI-Device Identifier20643169541706
UDI-Public(01)20643169541706(017)20180602
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/02/2018
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Device Lot NumberL047P
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/21/2018
Initial Date FDA Received07/13/2018
Date Device Manufactured12/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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