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

Model Number MMT-1715K

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Obstruction of Flow (2423); Battery Problem (2885); Power Problem (3010); Priming Problem (4040)

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

Event Date 03/04/2022

Event Type  malfunction  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Information received by medtronic indicated that the insulin pump was rejecting new batteries and and customer had to change the batteries in less than 7 days.Customer reported that the insulin pump was making grinding noise and was louder during rewind.Insulin pump also had no delivery alerts.No harm requiring medical intervention was reported.The device is not expected to be returned for analysis.

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.Retainer ring = black.On 03/04/2022, the customer alleged no delivery/occlusion alarms, back light anomaly, charge/battery lasts less than expected, failed battery test alarm, prime/fill anomaly, and rewind anomaly.No backlight anomaly was noted during testing.Pump passed the self-test, displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, sleep current measurement, active current measurement, and occlusion test.No unexpected insulin flow blocked, failed battery test, prime/fill anomaly, nor rewind anomaly alarms noted during testing.Pump successfully downloaded to thus.No confirmed no delivery, failed battery test, prime/fill anomaly, nor rewind anomaly alarms in the pump downloaded history.The power management graph confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within spec range.In further full review in the pump history, no battery related alarms were found on the event date of 03/04/2022.The electronic assemblies and motor assemblies were inspected, and no anomalies noted.Force sensor zero offset within specification (22.5mv).Motor was taken to the test bench where it rewound with no errors or alarms noted.The following were noted during visual inspection: cracked case above arrow and battery icon and pillowing keypad overlay.In summary, pump passed required testing.Customer alleged for no delivery/occlusion was not confirmed.Customer alleged for rewind anomaly was not confirmed.Customer alleged for prime/fill anomaly was not confirmed.Customer alleged for charge/battery lasts less than expected was not confirmed.Customer alleged for failed battery test alarm was not confirmed.Customer alleged for backlight anomaly was not confirmed.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.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: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 13691650
• MDR Text Key: 289895088
• Report Number: 2032227-2022-121579
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316631
• UDI-Public: (01)000000763000316631
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG47VYP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 95 KG