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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-523RNAP; 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-523RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-523RNAP
Device Problems Connection Problem (2900); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 12/25/2020
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
 
Event Description
The customer's daughter reported via phone call that they were hospitalized for high blood glucose and diabetic ketoacidosis on (b)(6) 2020.Blood glucose reading when admitted to hospital was 489 mg/dl.The customer was treated with intravenous insulin drip, fluids and antibiotics at the hospital.The customer stated that insulin pump had cracked retainer ring and reservoir was not able to lock into place.The insulin pump will be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
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
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
*   00777-3869
8185464805
MDR Report Key11100103
MDR Text Key224514704
Report Number2032227-2020-222802
Device Sequence Number1
Product Code OYC
UDI-Device Identifier000000643169513082
UDI-Public(01)000000643169513082
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 12/31/2020
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-523RNAP
Device Catalogue NumberMMT-523RNAP
Device Lot NumberA1523RNAPJ
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/28/2020
Initial Date FDA Received12/31/2020
Date Device Manufactured03/31/2015
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 Age82 YR
Patient Weight54
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