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

Model Number MMT-1715KL

Device Problems Break (1069); Connection Problem (2900)

Patient Problem Hypoglycemia (1912)

Event Date 04/15/2022

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 experienced low blood glucose.The customer¿s blood glucose level was 39 mg/dl.The customer¿s current blood glucose value was 97 mg/dl.The customer did not experienced symptoms of low blood glucose value.The customer treated low blood glucose with food.The customer was neither in the emergency room, nor admitted into hospital as a result of low blood glucose.It was unknown if the customer was using auto mode or not at the time of incident.Customer stated that the retainer ring was damaged.The reservoir was not able to lock in place.No harm requiring medical intervention was reported.Troubleshooting was performed and the customer will discontinue to use the device.

Manufacturer Narrative

Retainer ring = black.Customer returned pump for alleged cosmetic damage located at the retainer reservoir found on (b)(6) 2022.Allegations to low bgs noted.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 0.08735 inches.Successfully downloaded history files and traces using thus.Device was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor or force sensor.However, damage to the retainer ring was noted during visual inspection.The following were noted during visual inspection: scratched case, pillowing keypad overlay, cracked keypad overlay, damaged display window cover, cracked case, cracked case (battery tube), and broken battery tube threads.Cosmetic damage at retainer reservoir was not confirmed; however, other cosmetic damage was noted.Unable to verify customer alleged for low bgs.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-1715KL 630G
• 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: 14185597
• MDR Text Key: 289867911
• Report Number: 2032227-2022-182474
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)240714
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2024
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5H3YQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 07/29/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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 Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 100 KG