MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number	MMT-1715K
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.Unit passed the self-test.However, unit was not able to perform the displacement test due to missing retainer.The history was download successfully using thump software.Pump properly paired with accu-chek guide link bg meter.No communication anomaly noted.Unit received with broken reservoir tube lip, missing display window cover, fading serial number label and cracked case near belt clip rails.The unit p-cap / test reservoir locks in place properly.Unit was not confirmed for possible bg's meter inquiry anomalies.However, unit was not able to perform the displacement test due to missing retainer.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported to medtronic minimed that the customer had different meter readings.The customer reported no adverse event.The event involved in the product was mmt-1715k.Troubleshooting was not performed.No harm requiring medical intervention was reported.Product return is required for mmt-1715k.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• Common Device Name: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• 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: lusine boyadzhyan ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 19307388
• Report Number: 2032227-2024-168245
• Device Sequence Number: 12361563
• Product Code: OZO
• UDI-Device Identifier: 00763000090197
• UDI-Public: (01)00763000090197
• Combination Product (Y/N): N
• PMA/510(K) Number: P150001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG2LS89
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0955-2020
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Unknown