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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Hypoglycemia (1912); Anxiety (2328); Sweating (2444); Shaking/Tremors (2515)
Event Date 12/12/2018
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 reported via phone call that they experienced low blood glucose.The customer blood glucose level was 48 mg/dl at the time of incident and the current blood glucose of the customer was 230 mg/dl.Customer experienced symptoms such as shaking, sweating, anxiety.The customer was treated with food.Customer had using insulin pump system within 48 hours of reported high blood glucose event.Customer alleging insulin pump was over delivering.The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Device passed the self test, sleep current measurement, active current measurement, rewind test, prime test, basic occlusion test, occlusion test, force sensor test, displacement test, and the delivery accuracy test.Device was programmed with multiple boluses and monitored.All boluses delivered properly and were listed in the daily history screen.Device then was programmed with multiple basal profiles and monitored.All basal profiles delivered their indicated amounts and were verified in the daily and summary history screens.The units left at the insulin pump display matched properly the units left at test reservoir.No delivery anomaly, bolus anomaly or basal anomaly noted during testing.
 
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Brand Name
630G INSULIN PUMP MMT-1715K 630G BLACK MG
Type of Device
ARTIFICIAL 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 Key8198884
MDR Text Key131476056
Report Number2032227-2018-79763
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169656840
UDI-Public(01)00643169656840(17)180114
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 Other
Type of Report Initial,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/14/2018
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1Y956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2019
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/23/2018
Initial Date FDA Received12/27/2018
Supplement Dates Manufacturer Received03/25/2019
Supplement Dates FDA Received04/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age84 YR
Patient Weight122
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