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 Circuit Failure (1089)

Patient Problem Hyperglycemia (1905)

Event Date 03/11/2022

Event Type  Injury  

Event Description

It was reported that the customer was experiencing high blood glucose.Customer blood glucose was 33 mmol/l at the time of incident.Customer current blood glucose was 14 mmol/l.No treatment was given to the customer for high blood glucose.Customer stated that the insulin pump had pump error alarm.Customer stated that the insulin pump was beeping.No further complications were reported.Troubleshooting successfully performed and the customer will discontinue to use the insulin pump.

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.

Manufacturer Narrative

Pump was received with a missing reservoir tube o-ring, a broken reservoir tube lip and a missing retainer.Pump passed the self test, active current measurement, rewind test, prime/seating test, basic occlusion test and force sensor test.Unable to lock a test p-cap into the reservoir compartment and perform the displacement test, displacement accuracy test and occlusion test due to a missing reservoir tube o-ring, a broken reservoir tube lip and a missing retainer.Also, the pump had a high sleep current measurement.Successfully downloaded history files and traces using thus.Successfully downloaded comlink3 file.Power management graph was successfully generated.The power management tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) were within spec range.No alarms/alerts were noted during the testing.No power error 25, low battery alert, power loss alarm and replace battery alert/replace battery now alarm recorded in the formatted history file for the event date.Pump was cut open to perform visual inspection and found corrosion on the pcba 1 and pcba 2.No corrosion or moisture damage found on the force sensor, motor and vibrator assembly noted.The original pcba 2 was cleaned, installed in a test pcba 1, case, internal battery and motor.Powered the pump on using the battery simulator and continued testing.The pump passed the sleep current measurement.The original pcba 1 was cleaned, installed in a test pcba 2, case, internal battery and motor.Powered the pump on using the battery simulator and continued testing.The pump failed the sleep current measurement.The pump had a high sleep current measurement due to corrosion on the pcba 1.Per r&d engineer, there was no evidence of critical pump error (open book image) alarm in the history/traces/comlink data.However, pump error 24 was generated since the motor health check failed ( the motor vcc was less than 2.9v).Suspecting the hw.The following were also noted during visual inspection: a cracked keypad overlay, a pillowing keypad overlay, a scratched case, a cracked case-corner of belt clip rails near the battery tube compartment and a serial number label fading.A missing reservoir tube o-ring, a broken reservoir tube lip and a missing retainer were confirmed.Unable to verify customer alleged for high bgs.Critical pump error (open book image) alarm was not confirmed.Pump error 24 alarm and unexpected battery power loss or replace battery alert/replace battery now alarm were confirmed.Pump error 24 alarm due to corrosion on the pcba 1 and pcba 2.Unexpected battery power loss or replace battery alert/replace battery now alarm due to corrosion on the pcba1.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: 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
• 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: 13787305
• MDR Text Key: 287924014
• Report Number: 2032227-2022-142354
• 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,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• 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: HG1S4UC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• 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
• Treatment: FRN-UNK-RSVR,UNOEMD SET
• Patient Outcome(s): Other