MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KL

Device Problems Break (1069); Connection Problem (2900)

Patient Problem Hyperglycemia (1905)

Event Date 04/16/2022

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

Customer reported via phone call that they were hospitalized due to high blood glucose level on an unknown date.Customer's blood glucose value was above 700 mg/dl at the time of the incident.The customer declined troubleshooting for high blood glucose.Customer did not allege insulin pump was under delivering.Customer reported that the retainer ring was damaged.No further complications were reported.The customer will continue to use the product.

Event Description

It was reported that customer stated the reservoir lip was damaged.

Manufacturer Narrative

The information provided with initial mdr was incomplete.The complete information has been updated in b5 section of this report.

• Brand Name: 630G INSULIN PUMP MMT-1715KL 630G
• Type of Device: ARTIFICIAL 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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 14134364
• MDR Text Key: 289424039
• Report Number: 2032227-2022-180087
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)240830
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5MYZ2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-MMT-332-RSVR, UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 59 KG