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 Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 11/14/2021

Event Type  Injury  

Event Description

The customer reported via phone call that they were hospitalized due to low blood glucose on (b)(6), 2021 with blood glucose of 32 mg/dl.Customer stated other blood glucose level was 57 mg/dl.The customer did experienced the symptoms such as sweat and fuzziness.The customer was treated with juice and chocolate.Troubleshooting was done for low blood glucose and over delivery.The customer report did allege over delivery on insulin pump.The insulin pump will not be returned for analysis.

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.

• 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; * 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 Key: 12880607
• MDR Text Key: 281318099
• Report Number: 2032227-2021-223468
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 0000007630003166
• UDI-Public: (01)0000007630003166(17)240719
• 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
• Report Date: 11/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2024
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5HJBN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 11/29/2021
• Date Device Manufactured: 07/20/2021
• 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: UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 54 KG