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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1762K 670G V4.11 GS3 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1762K 670G V4.11 GS3 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1762K
Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Patient Problems Hyperglycemia (1905); Nausea (1970); Palpitations (2467)
Event Date 05/03/2020
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
It was reported that they were hospitalized in emergency room due to high blood glucose on (b)(6) 2020 with blood glucose level was above 15. 8 mmol/l. Customer experienced symptoms such as nausea, palpitations. The customer was treated with line change and manual injection after 4 hours. Customer was alleging insulin pump was under delivery after visiting emergency room, she changed the set again at home and he blood glucose started going high again. Customer declined to test insulin pump. The customer stated that they received insulin flow blocked alarm. Customer was using insulin pump system within 48 hours of reported high blood glucose event. It was unknown if the insulin pump was on auto mode at the time of the incident. The insulin pump will not be returned for analysis.
 
Manufacturer Narrative
Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test. No unexpected insulin flow blocked alarm noted. Device received with scratched case and pillowing keypad overlay. (b)(4).
 
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Brand NameKIT MMT-1762K 670G V4.11 GS3 MM
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
8185464805
MDR Report Key10031606
MDR Text Key190110237
Report Number2032227-2020-114401
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1762K
Device Catalogue NumberMMT-1762K
Device Lot NumberHG3TC6M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2019
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: 05/07/2020 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET
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