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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAS
Device Problems Failure to Cycle (1142); Detachment of Device or Device Component (2907); Priming Problem (4040)
Patient Problem Hyperglycemia (1905)
Event Date 05/12/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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
The customer reported via phone call that they experienced high blood glucose. The customer¿s blood glucose level was over 400 mg/dl at the time of incident. Customer treated high blood glucose with manual injection. Customer stated that the insulin was squirting out instead of dripping. Customer stated that the drive support cap appears normal slightly intended. No further patient complications were reported. Troubleshooting was performed; however, the customer will continue use of the device.
 
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Brand Name530G INSULIN PUMP MMT-551NAS
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key14433576
MDR Text Key292036271
Report Number2032227-2022-192055
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000643169503663
UDI-Public(01)000000643169503663
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 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-551NAS
Device Catalogue NumberMMT-551NAS
Device Lot NumberA4551NASJ
Was Device Available for Evaluation? No
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/17/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/19/2022 Patient Sequence Number: 1
Treatment
FRN-MMT-326-RSVR, UNOMED INF SET
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