MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number MMT-332A

Device Problems Break (1069); Insufficient Flow or Under Infusion (2182); Connection Problem (2900); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553)

Event Date 05/14/2019

Event Type  Injury  

Event Description

Medtronic legal received information from the attorney of the family on (b)(6) 2022. the reporter allegedly malfunctioned and did not deliver the proper amount of insulin to treat type 1 diabetes. the reporter alleges the claimant suffered hyperglycemia with a blood glucose of 400 mg/dl, and diabetic ketoacidosis resulting in hospitalization from (b)(6) 2019, to (b)(6) 2019. the reporter experienced symptoms were vomiting, nausea, urination, confusion, abdominal pain, and chest pain. the reporter alleged that the insulin was under-delivered by the insulin pump and the retainer ring was defective and the customer experienced difficulty in locking the reservoir into the pump. the allegation specifies the pump identifier (b)(4) and therefore all 600 series insulin pumps in possession of the claimant, including this pump, are considered potentially within the scope of the report confirmation of the affected serial number(s).The insulin pump was not expected to 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.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.

• Brand Name: RESERVOIR 3ML MMT-332A
• 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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 16110320
• MDR Text Key: 306778196
• Report Number: 2032227-2023-102668
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-MMT-332A-RSVR, UNOMED INF SET
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 66 KG