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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 Connection Problem (2900); Patient Device Interaction Problem (4001)
Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)
Event Date 04/27/2020
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. 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
The customer reported via phone call that they were hospitalized due to high pressure issues and hyperglycemia. The customer's blood glucose level at the time of incident was 200 mg/dl. Customer did not have information of hospitalization. The customer also reported that the ring came off and the reservoir was not able to lock in place. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Device passed the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test and force sensor test. Unable to perform the displacement test, occlusion test and delivery accuracy test due to missing retainer. The test p-cap and reservoir will not lock in place in the reservoir compartment due to missing retainer. Device also had a missing reservoir tube o-ring, scratched case, faded serial number label, stained keypad overlay, pillowing keypad overlay, cracked keypad overlay at the select button and a scratched keypad overlay. Device uploaded properly using carelink.
 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key10113786
MDR Text Key193592549
Report Number2032227-2020-125862
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG35BKZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-0955-2020

Patient Treatment Data
Date Received: 06/03/2020 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET
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