MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAL; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number	MMT-751NAL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received by medtronic indicated that the customer reported motor error 3 times.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer will discontinue using the insulin pump and it was returned for analysis.
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.Unit passed rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test.No unexpected motor error alarm noted during testing.Pump history download using thds was successful.However, a47 alarms found on the history file which caused corrupted data.Unable to confirm the reported event date due to the corrupted data.A47 alarms are due to the pump not having power for a long period of time.Pump was cut and open found no moisture/damage on the electronics, battery connector, battery tube, motor, vibrator, keypad flex tail noted during visual inspection.Motor passed motor test.The test reservoir locked in place properly and no anomaly noted.Unit had scratched case, cracked battery tube threads, cracked reservoir tube lip, stained address/serial number label and missing end cap sticker.Unit passed all required test.Motor error alarm was not confirmed.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 19587420
• Report Number: 2032227-2024-190084
• Device Sequence Number: 7214315
• Product Code: OZO
• UDI-Device Identifier: 00643169503694
• UDI-Public: (01)00643169503694
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A4751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female