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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED SENSOR ENLITE MMT-7008B ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008B
Device Problems Fracture (1260); No Apparent Adverse Event (3189)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/13/2021
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 they were dispatched by the emergency medical services due to needle broken in body on (b)(6) 2021. Needle was taken out at the hospital. Customer stated that the needle was broken underneath pedestal. Customer¿s mother claims that she did not touch the child right now, as it was screaming and crying. The sensor will not be returned for analysis.
 
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Brand NameSENSOR ENLITE MMT-7008B
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
tricha miles
18000 devonshire st.
northridge, CA 91325-1219
7635140379
MDR Report Key12486314
MDR Text Key271853938
Report Number2032227-2021-194216
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-7008B
Device Catalogue NumberMMT-7008B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/17/2021 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET
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