MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problem Unintended Movement (3026)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer returned pump for an alleged pump error 43 and pump error 130 found on (b)(6) 2021.Pump passed the self-test, displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test and occlusion test.No unexpected pump error alarms noted during testing.Successfully downloaded history files and traces using thus.Confirmed pump error 43 (motor drive error) alarm on (b)(6) 2021 at 7:19 and 7:23, (b)(6) 2021 at 1:42 and 1:43, and (b)(6) 2021 at 6:03, 6:04, 6:06, and 6:08 in the pump downloaded history.Confirmed pump error 130 alarm(mfda alarm) on (b)(6) 2021 at 7:18 and 7:19, (b)(6) 2021 at 1:36, 1:42, 1:44, 1:45, 7:30, and 23:39, and (b)(6) 2021 at 5:57 and 6:03 in the pump downloaded history.The electronic assemblies and motor assemblies were inspected and moisture damage found on the motor contact and corroded battery tube was noted.Force sensor zero offset within specification (21.5mv).Motor was taken to the test bench where it rewound with no errors or alarms noted.The following were noted during visual inspection: pillowing keypad overlay, cracked keypad overlay, and cracked retainer.In summary, pump passed required testing.Customer alleged for pump error 43 was confirmed on (b)(6) 2021 and (b)(6) 2021.Customer alleged for pump error 130 was confirmed on (b)(6) 2021.Moisture damage was confirmed on the motor contact and corroded battery tube.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 insulin pump alarmed multiple pump error alarm.Customer was able to clear the alarm and rewind the insulin pump.The displacement and self test were passed.No harm requiring medical intervention was reported.Troubleshooting was performed.The device will be returned for the analysis.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, 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: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 13740785
• MDR Text Key: 297057352
• Report Number: 2032227-2022-124241
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169782396
• UDI-Public: (01)000000643169782396
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG1VELN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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