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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-723NAH
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Lethargy (2560)
Event Date 08/01/2021
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
Customer's father reported via phone call that the customer went to emergency room due to high blood glucose level.Customer's blood glucose was ranging from 177 mg dl to 400 mg/dl at the time of hospitalization.Customer was hospitalized in emergency room on (b)(6) 2021 for 8 hours.Customer reported nausea, vomiting, irritation and lethargic symptoms at the time of hospitalization.Customer's ketone level was high.Customer was treated with intravenous insulin drip and dextrose drip intravenous saline and bolus at the hospital.Troubleshooting was not performed.The insulin pump will not be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
Type of Device
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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 Key12322524
MDR Text Key266590395
Report Number2032227-2021-180553
Device Sequence Number1
Product Code OYC
UDI-Device Identifier000000643169507227
UDI-Public(01)000000643169507227
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 08/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-723NAH
Device Catalogue NumberMMT-723NAH
Device Lot NumberB5723NAHJ
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/04/2021
Initial Date FDA Received08/15/2021
Date Device Manufactured07/06/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
FRN-UNK-RSVR, UNOMED SET
Patient Outcome(s) Hospitalization;
Patient Age10 YR
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