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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 Inaccurate Delivery (2339); Low Test Results (2458)
Patient Problem Hypoglycemia (1912)
Event Date 04/28/2018
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

Customer's parent reported via phone call that the customer experienced low blood glucose on (b)(6) 2018 with blood glucose of 42 mg/dl at the time of the incident. The customer started having the lows after playing sports. The customer was at 278 mg/dl at the time of the call. The customer was given food to treat. The customer was wearing the insulin pump during the incident. The caller stated the pump was over delivering as they would eat, take off the pump to play sports, put the pump back on, and then go low. Troubleshooting was completed but did not resolve the issue. The insulin pump will be returned for analysis.

 
Manufacturer Narrative

The device alarmed motor error during basic occlusion test due to faulty force sensor resistor. Unable to perform rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test or verify possible under or over delivery due to motor error alarm. The device was received with normal operating currents and passed unexpected restart error test and self-test. Motor passed the motor test.

 
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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
MDR Report Key7547977
MDR Text Key109366068
Report Number3004209178-2018-74545
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,Followup
Report Date 07/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-751LNAL
Device Catalogue NumberMMT-751LNAL
Device LOT NumberA5751LNALJ
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/17/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/29/2018 Patient Sequence Number: 1
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