MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711K

Device Problem Break (1069)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Diabetic Ketoacidosis (2364)

Event Date 05/06/2021

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

It was reported via phone call by the customer's parent that the customer got hospitalization due to high blood glucose on (b)(6) 2021 with blood glucose of 630 mg/dl at the time of the incident.The customer had an infection and diabetic ketoacidosis.The customer was at 194 mg/dl at the time of the call.The customer was given intravenous insulin to treat.The caller did not mention any symptoms.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed as the caller declined.The insulin pump has a crack on the back of the casing.The customer's doctors believe the pump has a fault.The insulin pump will be returned for analysis.

• Brand Name: 640G INSULIN PUMP MMT-1711K
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 11817311
• MDR Text Key: 250369968
• Report Number: 2032227-2021-145021
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000192136
• UDI-Public: (01)000000763000192136
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Device Lot Number: HG35MLX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Date Device Manufactured: 02/06/2019
• 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 SET
• Patient Outcome(s): Hospitalization