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

Model Number MMT-754LCMS

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hyperglycemia (1905); Blurred Vision (2137)

Event Date 09/17/2021

Event Type  malfunction  

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.

Event Description

Information received by medtronic indicated that the insulin pump had possible damage on drive support cap.Customer was unable to describe damage.They experienced high blood glucose level of 28 mmol/l.The device will not be returned for analysis.

Manufacturer Narrative

On sep 17, 2021 the customer returned pump for an alleged high bg and loose drive support disk.Device passed the displacement test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test.However, no damage to the support disk was found during the analysis¿.Pump history download using thds was successful.High bg confirmed was shown on down load report was on 12/09/21 21:56:50 alarm #4 - alrm_counts_exceeded - excessive pump counts.The following were noted during visual inspection: broken belt clip slot, stained end cap sticker, stained address/serial number label and cracked reservoir tube lip.The test p-cap/reservoir does lock into place.No moisture damage found on the electronics, motor, battery tube and vibrator assembly noted.Device passed require testing.Unable to confirm alleged high bg and loose drive support disk.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LCMS
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 12531526
• MDR Text Key: 273290668
• Report Number: 2032227-2021-198195
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000161262
• UDI-Public: (01)000000763000161262
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754LCMS
• Device Catalogue Number: MMT-754LCMS
• Device Lot Number: A3754LCMSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• 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