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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-722NALL; 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-722NALL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number MMT-722NAL
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Headache (1880); Hyperglycemia (1905); Polydipsia (2604)
Date of Event 06/29/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The customer reported via phone call that they experienced high blood glucose.Blood glucose reading went up to 420 mg/dl.Customer had symptoms as headache and dry mouth.The insulin pump will not be returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL
Common Device Name
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
MDR Report Key10256285
Report Number2032227-2020-144418
Device Sequence Number2360035
Product Code OYC
UDI-Device Identifier00613994622570
UDI-Public(01)00613994622570
Combination Product (Y/N)N
Initial Reporter CountryBR
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/09/2020
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
Operator of Device Lay User/Patient
Device Model NumberMMT-722NAL
Device Catalogue NumberMMT-722NAL
Device Lot NumberB2722NALJ
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2020
Initial Report FDA Received Date07/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
FRN-UNK-RSVR, UNOMED INF SET
Outcome Attributed to Adverse Event Other;
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