MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 10-PACK RESERVOIR MMT-342 10PK EXTENDED; PUMP, INFUSION

Model Number MMT-342

Device Problems Improper Flow or Infusion (2954); Appropriate Term/Code Not Available (3191)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 08/16/2023

Event Type  Injury  

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Information received by medtronic indicated that the customer experienced hypoglycemia with a blood glucose value of 45 mg/dl and was treated with glucose or carb intake.Customer woke up with high sensor glucose alerts.Customer experienced hyperglycemia of blood glucose value 427 mg/dl.Customer did not experienced any symptoms due to low blood glucose.In addition to that customer reported airbubbles were observed which led to cause low and high blood glucose.Troubleshooting was performed and found that the pump was used within 48 hours of reported low blood glucose event and the auto mode feature was active at the time of the event.No further patient complications were reported.Customer will continue using the insulin pump.The insulin pump will not be returned for analysis.

• Brand Name: 10-PACK RESERVOIR MMT-342 10PK EXTENDED
• Type of Device: PUMP, INFUSION
• 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: justin ellis ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635265677
• MDR Report Key: 17667872
• MDR Text Key: 322468024
• Report Number: 2032227-2023-265713
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 002076300049718101
• UDI-Public: (01)002076300049718101(17)260329(10)HG6ZBCD
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-342
• Device Catalogue Number: MMT-342
• Device Lot Number: HG6ZBCD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2023
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: FRN-MMT-342-RSVR, UNOMED SET.
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male