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 Excess Flow or Over-Infusion (1311); Appropriate Term/Code Not Available (3191)

Patient Problem Hypoglycemia (1912)

Event Date 11/28/2021

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¿s husband reported via phone call that customer experienced low blood glucose level.Customer stated the sensor reading showed low and they had changed set and there was less insulin than they had expected.Customer's blood glucose level at the time of incident was 48 mg/dl.Customer alleged that the insulin pump was over delivering insulin because when they checked reservoir and it had less insulin than it should have.Customer treated low blood glucose level with food.Customer¿s current blood glucose level was 154 mg/dl.Customer had been using the insulin pump system within 48 hours of reported event.Customer was assisted with troubleshooting.The insulin pump will be returned for analysis.

Manufacturer Narrative

Retainer = black.Customer returned insulin pump for an alleged low blood glucose found on june 04, 2020.Insulin pump passed the self test, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test.No unexpected no delivery/occlusion alarm or motor error alarm noted during testing.Insulin pump was cut open to perform visual inspection and no physical damage or moisture damage found on the electronic assembly, motor assembly and force sensor assembly.Motor passed the motor test outside of the device.The force sensor measurement was within spec range (22.3mv).Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: minor scratched liquid crystal display window.In summary, insulin pump passed all required testing.Unable to verify customer complaint for low blood glucoses.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: 12966869
• MDR Text Key: 281973972
• Report Number: 2032227-2021-228572
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000316655
• UDI-Public: (01)000000763000316655(17)240502
• 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: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/02/2024
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG5A72A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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
• Treatment: FRN-MMT-332A-RSVR, UNOMED INF SET
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 170 KG