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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-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KL
Device Problems Connection Problem (2900); Patient Device Interaction Problem (4001)
Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); Blood Loss (2597)
Event Date 06/07/2020
Event Type  malfunction  
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 hyperglycemia. The customer blood glucose level was around 300 mg/dl or 400 mg/dl. Customer gave himself the injections to treat the blood glucose. Customer also noticed that reservoir sometimes comes out and it was not locking in place. The ring where the reservoir goes it did not appear corroded or damaged. Customer also reported bruise, hematoma and blood at the site. The device will be returned for analysis.
 
Manufacturer Narrative
Device p-cap or reservoir locked properly in place. Device passed displacement test, self test, rewind, prime or seating, basic occlusion, force sensor test and occlusion test. Device received with cracked retainer. (b)(4).
 
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Brand Name630G INSULIN PUMP MMT-1715KL 630G
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 Key10166199
MDR Text Key195529865
Report Number2032227-2020-132624
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 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/11/2022
Device Model NumberMMT-1715KL
Device Catalogue NumberMMT-1715KL
Device Lot NumberHG3L1D1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2020
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2019
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: 06/18/2020 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVRUNOMED SET
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