MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754CAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-754CAS

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Abdominal Pain (1685); Hyperglycemia (1905); Nausea (1970); Vomiting (2144)

Event Date 05/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).On the event date (b)(6) 2020.Customer returned pump for an alleged high blood glucoses.Unable to perform stop current, run current, self test, off no power, a21 error test, rewind, basic occlusion, occlusion, prime/a33, excessive no delivery test and displacement test due to blank display.Unit received with blank display due to severe corroded battery tube.Unable to download pump history file due to blank display.Try to download the pump by using test case.Insulin pump history successfully downloaded.However, a47 alarms found on the history file which caused corrupted data.Unable to confirm the reported event date/button error alarm due to the corrupted data.Unit was cut/open and inspected no moisture damage or component damage found inside the insulin pump.The test p-cap/reservoir does lock into place.The following were noted during visual inspection: no cosmetic damage found.Confirmed blank display due to corroded battery tube.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 they were experiencing hyperglycemia and insulin pump was under delivering.Patient's blood glucose at time of incident was 500 mg/dl.Customer had positive result in ketone test.Customer experiencing symptoms such as nausea, vomiting and abdominal pain.Customer stated that they were using insulin pump with the 48 hours of that incident.No harm requiring medical intervention was reported.The device was returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754CAS
• 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: 16056623
• MDR Text Key: 306215574
• Report Number: 2032227-2022-388957
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2022

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 Model Number: MMT-754CAS
• Device Catalogue Number: MMT-754CAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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