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 Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Sweating (2444); Confusion/ Disorientation (2553)

Event Date 07/29/2020

Event Type  malfunction  

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

Complaints text (b)(6) 2020 23:08:57 erp_rfc_user related svn (b)(4).Complaints text (b)(6) 2020 22:58:12 (b)(6) customer concern: low bg dop114-980doc: low bgs/over delivery what led up to the event?: pt not doing anything, sleeping, got new pump document current bg value: 70 mg/dl how has customer treated for low bgs?: treated with food how long has customer been experiencing low bg?: since july, since new pump is in use does customer show symptoms of low bg?: yes indicate which symptoms customer is reporting.Shaking sweating mental confusion weakness advise customer to follow the guidelines outlined in the ifu to treat symptoms of low bg.Remain on phone with customer.If needed instruct customer to take a fast acting glucose source, e.G.Glucose tab, 1 tsp honey, 4oz soda, 1tsp sugar.Document how customer treated bg as applicable: pt took food if needed suspend pump or disconnect.Recheck bg in 15 minutes and document updated bg value.If not above 70 mg/dl, repeat treatment and check again 15 mins and document bg once more.Get help from someone with customer if needed.Instruct customer to follow up with their hcp once bgs are stable.If customer is confused, uncooperative or not responsive contact ems (911/police/sheriff) as per dop 114 - 680.Request assistance to contact ems as needed: customer declined does customer feel ok to troubleshoot?: yes has customer been using the insulin pump system within 48 hours of reported low bg event?: yes was customer in er, admitted into hospital, or ems dispatched as a result of low bg?: no document why the customer alleges pump is over delivering: pt confirmed with hcp, settings are all good what was the customer doing prior to the event? (document any programming, fill tubing, reconnect/disconnect, etc.): pt said that she eats less now, settings is from old pump she's using when she eat big meals document the exact time frame of when the event began (date/ time): jul 29 2020 / 23:00 does customer use a linked meter?: yes document meter id: pt doesn't know.Pt does not feel well to check it, pt is blind did the customer get assistance with programming the pump?: yes document the time/date of the most recent (last) set change: 10:00 / jul 29 2020 inquire if during the last set change customer recalls insulin dripping or squirting from end of set before connecting at their site.Document findings: normal was the patient disconnected during the rewind/prime sequence?: yes explain importance of disconnecting during prime/rewind sequence.Review priming technique.Is insulin type and concentration correct based on hcp guidance?: yes advise customer when removing/inserting reservoir positioning in motor may have shifted: yes advise customer to always complete rewind/load reservoir process before connecting back to set: yes review pump programming (time/date, am/pm, basal rates, bolus wizard settings, total daily doses (tdd), etc.).Is programming accurate?: yes advise customer to disconnect from set and remove the reservoir from the pump.Advise customer to check the status screen and then visually inspect the reservoir: yes reservoir is showing: same amount of insulin as shown on status review health/lifestyle issues (unusual events, overbolus to correct high bg, recent basal rate changes, etc.).Does customer report any unusual events?: no advise customer to avoid exposure to any strong magnetic fields associated with mris.Was the pump worn during a test done during or near an mri or was pump exposed to strong magnet?: no is customer able to upload to carelink at this time?: no document why customer is not able to upload: pt wants to rest, have to go.Pt said she is feeling a lot better advise customer to complete carelink upload before pump return if possible and to call for assistance with upload if needed: customer unable to complete advise customer the pump wil go to record for full text.

Manufacturer Narrative

The narrative summary was missing with initial report.The summary has been provided in this report.(b)(4).

Event Description

Information received by medtronic indicated that the customer had experienced low blood glucose level and had alleged that the insulin pump was over delivering.Customer was treated with food.Customer had symptoms like shaking, sweating, mental confusion and weakness.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.The device will not be returned for analysis.

• 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: 10361039
• MDR Text Key: 202771632
• Report Number: 2032227-2020-157261
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000316631
• UDI-Public: (01)00763000316631
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• 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: HG491M1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• 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 Age: 61 YR
• Patient Weight: 160