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 Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Chills (2191)

Event Date 05/05/2021

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 the customer experienced hypoglycemia.The customer blood glucose level was last night she checked 101 mg/dl and 45 minutes later it bottomed out to 42 mg/dl and the current blood glucose level was 133 mg/dl.Customer experienced symptoms related to that was fatigue and chills.The customer was assisted with troubleshooting.The customer was treated with food for low blood glucose.Customer was using insulin pump system within 48 hours of reported low blood glucose event.Customer stated that they did alleging insulin pump for over delivery due to customer¿s last night blood glucose went to the 40 mg/dl.The insulin pump and reservoir will be returned for analysis.

Manufacturer Narrative

Device was received with a scratched case.The test reservoir does lock properly inside the reservoir tube.Device passed the functional tests, including the self test, sleep current measurement, active current measurement, rewind test, prime or seating test, basic occlusion test, occlusion test, force sensor test, displacement test and delivery accuracy test at 0.08750 inches.Device was programmed with multiple bolus deliveries and all bolus delivered properly their indicated amounts and were properly recorded in the daily history.No bolus delivery anomaly or history anomaly noted.No under delivery anomaly or over delivery anomaly noted during testing.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: 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
• MDR Report Key: 11806427
• MDR Text Key: 249985583
• Report Number: 2032227-2021-144354
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316631
• UDI-Public: (01)000000763000316631
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• 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: HG4J9Y7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNOMED SET, OZP-MMT-7020-SNSR; UNOMED SET, OZP-MMT-7020-SNSR
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 224