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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-751LNAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAL
Device Problem Obstruction of Flow (2423)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)
Event Date 12/01/2018
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
It was reported written report that the customer experienced diabetic ketoacidosis in (b)(6) 2018; the customer was hospitalized for this event. The customer also experienced unexplained no delivery alarms which they resolved by changing their infusion set, reservoir, and insulin. No further details were provided regarding the hospitalization details. Troubleshooting did not occur. The insulin pump was not returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751LNAL
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
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
8185464805
MDR Report Key8356866
MDR Text Key136721989
Report Number3004209178-2019-58085
Device Sequence Number1
Product Code OZO
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 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751LNAL
Device Catalogue NumberMMT-751LNAL
Device Lot NumberA4751LNALJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/04/2016
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: 02/21/2019 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR UNOMED SET
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