MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Loss of consciousness (2418)

Event Date 01/25/2022

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 reported via phone call that they were hospitalized due to hyperglycemia on (b)(6) 2022 for 4 days.The customer¿s blood glucose level was 970 mg/dl at time of incident.The customer was assisted with troubleshooting.The customer stated that the symptoms related to high blood glucose such as nausea, vomiting and passed out.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.The customer will discontinue the use of device.

Manufacturer Narrative

Retainer ring = clear.Customer returned insulin pump for an alleged was hospitalized for high bgs found on (b)(6) 2022.Also, on case-(b)(4), svn#: 000313822696 - customer returned pump for an alleged sensor anomaly found on (b)(6) 2022, on case-(b)(4), svn#: 000308210123 - customer returned pump for an alleged unexpected suspend and sg/bg anomaly found on (b)(6) 2018 and on case-(b)(4), svn#: 000308189603 - customer returned insulin pump for an alleged lost sensor alarm found on (b)(6) 2018.Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08680 inches.Successfully downloaded history files and traces using thus.Successfully uploaded pump to carelink.Device was programmed with contour next test glucose meter.The pump connected successfully to the test meter and displayed ¿bg meter connection successful¿.Device was programmed with contour next test glucose meter.The pump communicated properly and recorded the 75 mg/dl test value properly from glucose meter.The pump sensor feature is working properly.No unexpected bg meter communication errors or anomalies noted during testing.Device was programmed with a test guardian link (3) transmitter and a glucose sensor simulator.Device connected successfully to the transmitter and displayed ¿transmitter connection successful¿.Device communicated properly with glucose sensor simulator and displayed the calibrate your sensor alarm properly after completion of the warm up.The pump calibrated and displayed the programmed value of 240 mg/dl properly on the display graph.No unexpected lost sensor connection alarms or sensor anomalies noted during testing.Device was monitored and no unexpected suspend and sg/bg anomaly noted.Device was cut open to perform visual inspection and found no evidence of physical or moisture damage on the pcba1, pcba2, force sensor, motor and vibrator assembly noted.Force sensor zero offset within specification 22.6 mv).The motor was tested outside of the device on the ngp stb3 and passed.The test p-cap and reservoir locked properly into reservoir compartment.However, a cracked retainer was noted during testing.The following were also noted during visual inspection: a cracked keypad overlay, a pillowing keypad overlay, a cracked case and a scratched case.A cracked retainer was confirmed.Device passed all the required testing.Unable to verify customer alleged for high bgs.The force sensor is within specification and the motor functioning properly.Unexpected suspend, sg/bg anomaly, sensor anomaly and lost sensor alarm were not confirmed.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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-1715KM 630G 3ML BLACK MEDI
• 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: 13702840
• MDR Text Key: 287189162
• Report Number: 2032227-2022-121907
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169873834
• UDI-Public: (01)000000643169873834
• 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: 06/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG1JKWB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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-MMT-326-RSVR, UNOMED INF SET, OZO-MMT-7020-SN
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 45 KG