MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711K

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

Information received by medtronic indicated that label was missing, customer also stated that the backup was needed for battery cap for fa1249.No harm requiring medical intervention was reported.The insulin pump was returned for the analysis.

Manufacturer Narrative

(b)(4).The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.Customer returned pump for alleged cosmetic damage located at the serial number label and battery cap contact found on (b)(6) 2022.The insulin pump passed the displacement test and p-cap locks properly into the reservoir compartment.The following were noted during visual inspection: battery tube threads - cracked, serial number label missing, pillowing keypad overlay, battery cap contact missing.Cosmetic damage was confirmed at serial number label.The pump did not meet specifications due to missing battery cap contact.Unable to confirm battery cap contact damage due to original battery cap not sent with pump, however, other cosmetic damage was noted.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: 640G INSULIN PUMP MMT-1711K
• 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: 15541695
• MDR Text Key: 306280678
• Report Number: 2032227-2022-345319
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000317089
• UDI-Public: (01)000000763000317089
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Device Lot Number: HG4G2VB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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