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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-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAS
Device Problems Inaccurate Delivery (2339); Device Displays Incorrect Message (2591)
Patient Problem Hypoglycemia (1912)
Event Date 05/09/2018
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

It was reported that the customer experienced low blood glucose, with blood glucose of 50 mg/dl at the time of the incident. The customer used food to treat. The customer was wearing the insulin pump during the incident. The customer felt that the pump was over delivering. Troubleshooting was completed but did not resolve the issue. The customer also reported that they felt the pump was malfunctioning as there were no alarms on the pump. The customer stated they got a no delivery alarm on (b)(6) 2018 during manual prime, which was resolved by a complete set change. The insulin pump will be returned for analysis.

 
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Brand Name530G INSULIN PUMP MMT-751LNAS
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
MDR Report Key7576747
MDR Text Key110324516
Report Number3004209178-2018-78198
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Type of Report Initial
Report Date 06/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751LNAS
Device Catalogue NumberMMT-751LNAS
Device LOT NumberA5751LNASJ
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/02/2018
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: 06/07/2018 Patient Sequence Number: 1
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