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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 06/05/2022
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's family member reported via phone call that they were experienced high blood glucose level. Customer¿s blood glucose level was 407 mg/dl at the time of incident. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer's current blood glucose was 342 mg/dl. Customer was not assisted with troubleshooting for high blood glucose level. No further patient complication were reported. The device will not be returned for analysis.
 
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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
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key14798752
MDR Text Key294647432
Report Number2032227-2022-231810
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 06/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/11/2021
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG316XA
Was Device Available for Evaluation? No
Date Manufacturer Received06/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/12/2018
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: 06/24/2022 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED SET
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