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 Power Problem (3010); No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Loss of consciousness (2418)

Event Date 10/03/2020

Event Type  Injury  

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 Description

The customer's mother reported via phone call that customer was hospitalized due to high blood glucose on (b)(6) 2020 with blood glucose of 1200 mg/dl.Current blood glucose level was 400 mg/dl.The customer was treated with insulin drip in the hospital.Customer experienced symptoms of high blood glucose level such as nausea, vomiting, abdominal pain, difficulty breathing, and unconscious.The customer was reported that insulin pump was not on auto mode.Insulin pump had critical error alarm and also received another critical error alarm.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump error 35 alarm and critical pump error due to moisture damage on the electronic assembly.Unable to verify e/a alarm and perform the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement accuracy test and displacement test due to critical pump error (open book).The test p-cap does not lock in place properly due to missing retainer and missing reservoir tube o-ring.Device received with pillowing keypad overlay, cracked case corner of the belt clip rails near the battery compartment, cracked battery tube threads, cracked select button keypad overlay and keypad overlay texture damage.

Manufacturer Narrative

On (b)(6) 2020, the customer alleged device critical error (open book) and hospitalized high blood glucose.Device was received with a critical pump error (open book image) alarm.Unable to verify e/a alarm and perform the displacement test, rewind test, prime/seating test, basic occlusion test, force sensor test, occlusion test, sleep current measurement test, active current measurement test, displacement accuracy test and self test due to critical pump error (open book image) alarm.Unable to lock a test p-cap into the reservoir compartment due to missing retainer ring.Device was cut open to perform visual inspection and found moisture damage on the electrical board 1, battery tube and force sensor.Successfully downloaded history files and traces using thump.Critical pump error (open book image) alarm was triggered by a pump error 35 fatal alarm confirmed in the history file or traces on (b)(6) 2020 at 6:17:00 am due to moisture damage on the force sensor.Force sensor zero offset was out of specific range (444.3 milivolts).The following were noted during visual inspection: missing retainer o-ring, pillowing keypad overlay, cracked case corner of the belt clip rails near the battery compartment, cracked battery tube threads, cracked select button keypad overlay and keypad overlay texture damage.Unable to verify customer complaint for high blood glucoses.Critical pump error (open book image) alarm confirmed due to pump error 35 alarm.Pump error 35 alarm confirmed due to moisture damage on the force sensor.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.

Manufacturer Narrative

This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0955-2020.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: 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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 10682630
• MDR Text Key: 211424834
• Report Number: 2032227-2020-191443
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169656840
• UDI-Public: (01)000000643169656840
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• 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: HG1QCME
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0955-2020
• Patient Sequence Number: 1
• Treatment: FRN-UNK-RSVR, UNOMED INF SET.; FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 36 YR
• Patient Sex: Male