MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712 PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number MMT-712EWS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Select patient information cannot be provided due to regional privacy regulations.On (b)(4) 2022 the customer returned pump for an alleged low bg.Pump passed the displacement test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test.Pump history download using thds was successful however, on nov 07, 2022 there is no alarm reports event date noted.The following were noted during visual inspection: cracked 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.Pump passed require testing.Unable to confirm alleged low bg's.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 low blood glucose and pump had no alarm.Customer blood glucose level was 3.9 mmol/l.No harm requiring medical intervention was reported.Troubleshooting was performed.The device was returned for analysis.

• Brand Name: MMT-712 PARADIGM INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• 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: 16580849
• MDR Text Key: 311771437
• Report Number: 2032227-2023-174003
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 000000763000161019
• UDI-Public: (01)000000763000161019
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-712EWS
• Device Catalogue Number: MMT-712EWS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• 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