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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAS
Device Problems Break (1069); Excess Flow or Over-Infusion (1311); Detachment of Device or Device Component (2907)
Patient Problem Hypoglycemia (1912)
Event Date 10/01/2021
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
Information received by medtronic indicated that the insulin pump was over delivering as customer has been getting lows even setting has been adjusted. Customer also stated that drive support cap was slightly indented. Insulin pump had scratch on it. No harm requiring medical intervention was reported. Troubleshooting was performed; however, customer will discontinue the use of device.
 
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Brand Name530G INSULIN PUMP MMT-751NAS
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 Key14097433
MDR Text Key289777215
Report Number2032227-2022-178723
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
Type of Report Initial
Report Date 04/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Device Lot NumberA6751NASJ
Was Device Available for Evaluation? No
Date Manufacturer Received01/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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