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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-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAS
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 08/27/2018
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
Customer's grandparent reported via phone call that the customer got hospitalized due to low blood glucose on (b)(6) 2018 with blood glucose of 10 mg/dl at the time of the incident. The customer was at 191 mg/dl at the time of the call. The customer was given honey and glucagon shots to treat. The customer experienced symptoms such as seizures. The customer was wearing the insulin pump during the incident. The pump had physical damage and the caller believes the pump was over delivering. Troubleshooting was not completed. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Unit received with operating currents within specification. Unit passed self test, unexpected restart error test, displacement test and basic occlusion test. Unable to prime unit during prime test due to faulty force sensor resistor. Unable to perform occlusion test, delivery accuracy test and excessive no delivery test due to prime anomaly. Unit received with cracked case at display window corners, display window, reservoir tube lip, reservoir tube window, reservoir tube window corners and battery tube threads. Unit received with minor scratched display window and case. Unit received with stained end cap sticker and back address serial number label. Unit received with broken belt clip slot and stripped battery cap coin slot.
 
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Brand Name530G INSULIN PUMP MMT-751NAS
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 Key7875975
MDR Text Key120238989
Report Number2032227-2018-28099
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,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Device Lot NumberA3751NASJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2014
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: 09/14/2018 Patient Sequence Number: 1
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