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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 Problem Inaccurate Delivery (2339)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 05/08/2018
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 called and reported that they received emergency medical assistance due to low blood glucose on (b)(6) 2018 with blood glucose of 35 mg/dl at the time of the incident. The customer was at 117 mg/dl at the time of the call. The customer used glucose tablets to treat. The customer experienced symptoms such as seizures. The customer was wearing the insulin pump during the incident. The customer gets random lows and believes the pump may be over delivering. Troubleshooting was completed for the lows, but not completed for the highs as the customer declined. The customer also experiences highs of up to 400 mg/dl due to hardened tissue, and had a low of 50 mg/dl in 2017. The 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.

 
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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 Key7586178
MDR Text Key110586012
Report Number3004209178-2018-79502
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 07/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2018
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 NumberA4751LNALJ
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 Received06/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/14/2017
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: 06/11/2018 Patient Sequence Number: 1
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