MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 670G INSULIN PUMP MMT-1780KP; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1780KP
Medical Device Problem Codes	Mechanical Problem (1384); Connection Problem (2900); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional 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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer¿s mother reported via phone call that customer experienced hyperglycemia and reservoir did not able to lock in place when inserted into insulin pump.The customer blood glucose level was 461 mg/dl.Customer stated that the insulin pump was not rewound and the clear ring was broken off.Customer declined to troubleshoot and they took care of high blood glucose.It was unknown that if the insulin pump was in auto mode at the time of the incident.The insulin pump will returned for analysis.
Additional Manufacturer Narrative
Device received with missing retainer ring and reservoir tube lip o-ring.Device received with partially broken off piece at the reservoir tube lip.Unable to perform displacement test, occlusion test and p-cap or reservoir will not lock properly due to missing retainer.Device passed rewind, prime or seating, basic occlusion and force sensor test.No rewind anomaly noted during testing.
Additional Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0956-2020.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: 670G INSULIN PUMP MMT-1780KP
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• 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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 10138758
• Report Number: 2032227-2020-128793
• Device Sequence Number: 19368685
• Product Code: OZP
• UDI-Device Identifier: 00763000173043
• UDI-Public: (01)00763000173043
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-1780KP
• Device Catalogue Number: MMT-1780KP
• Device Lot Number: HG3FTG8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 10/14/2019
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/02/2020; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0956-2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED SET; FRN-UNK-RSVR,UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 46 KG