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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); Date/Time-Related Software Problem (2582)
Patient Problem Hyperglycemia (1905)
Event Date 04/26/2018
Event Type  Injury  
Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event. The device has been returned, but not yet evaluated. Further information will follow once the analysis has been completed. No conclusion can be drawn at this time.

 
Event Description

The customer reported via phone call that the insulin pump had time clock anomaly as well as insulin pump was under delivery. Customer¿s blood glucose level was high and it was 397 mg/dl. Customer reports that the clock was losing time and the loss was greater than 3 minutes within 10 days and gain is greater than 9 minutes within 30 days. Customer was advised to revert to back up plan. Insulin pump will be returned for analysis.

 
Manufacturer Narrative

Pump passed all functional tests, including the idle current measurement test, run current measurement test, self test, off no power test, unexpected restart error test, displacement test, basic occlusion test, occlusion test, prime test, rewind test, excessive no delivery test and delivery accuracy test. Pump programmed with the current time and date and monitored for several days. The time and date is functioning properly.

 
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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 Key7575807
MDR Text Key110320128
Report Number3004209178-2018-78093
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 PATIENT
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751LNAS
Device Catalogue NumberMMT-751LNAS
Device LOT NumberA5751LNASJ
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/25/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/21/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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