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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-722NAB
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 05/24/2018
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.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
Nurse reported via phone call high blood glucose levels and hospitalization.Customer¿s blood glucose level was 1400 mg/dl.Customer was admitted into the hospital on (b)(6) 2018.Customer¿s insulin pump malfunctioned, they went to the emergency room, experienced mental illness and back pain.Nurse advised customer was wearing the insulin pump at the time of the hospitalization.Nurse advised the patient¿s settings were lost and they would need a new insulin pump.Product was not returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAB
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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
MDR Report Key7648789
MDR Text Key112693353
Report Number3004209178-2018-86269
Device Sequence Number1
Product Code OYC
UDI-Device Identifier00613994622594
UDI-Public(01)00613994622594
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 06/28/2018
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-722NAB
Device Catalogue NumberMMT-722NAB
Device Lot NumberA6722NABJ
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/30/2018
Initial Date FDA Received06/28/2018
Date Device Manufactured07/20/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age51 YR
Patient Weight148
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