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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problems Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)
Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912); Weakness (2145); Anxiety (2328); Sweating (2444); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
Event Date 07/10/2020
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.

 
Event Description

The customer reported via phone call that they experienced high and low blood glucose. The customer¿s blood glucose level was 226 mg/dl and 40 mg/dl which was treated with manual injection for high blood glucose and food for low blood glucose. Customer was experienced symptoms like shaking, sweating, anxiety, mental confusion, inability to follow simple commands, weakness and fatigue. Customer was performed self and displacement test and it was pass. The customer also stated that they did allege insulin pump was under delivering. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer was neither in emergency room nor admitted into hospital. Customer stated that auto mode feature was not active. The insulin pump and reservoir will not be returned for analysis.

 
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Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI
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
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
8185464805
MDR Report Key10308194
MDR Text Key199870012
Report Number2032227-2020-150868
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
Type of Report Initial
Report Date 07/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device LOT NumberHG1KX9Q
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/03/2017
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: 07/22/2020 Patient Sequence Number: 1
Treatment
UNOMED INF SET
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