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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 Problems Device Alarm System (1012); No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 02/23/2020
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. (b)(4).
 
Event Description
The customer reported via phone call that they experienced the low blood glucose. The customer said insulin pump was vibrating because it was out of insulin and changed it then customer had seizure after few hours. The customer¿s blood glucose at the time of the incident was unknown. The customer was treated with the food. The drive support cap was normal. The customer had using the insulin pump system within 48 hours of the low blood glucose. The customer did not allege the insulin pump was over delivering. The device will be returned for the 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
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 Key9768078
MDR Text Key182470746
Report Number3004209178-2020-77674
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 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
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 Received02/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/12/2016
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: 02/28/2020 Patient Sequence Number: 1
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