MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-399T

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

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) 2018 erp_rfc_user related (b)(4).Complaints text (b)(6) 2018 (b)(6).Initial notes: cust called stating that he has a cpl of inf sets with some blocked cannulas.One on (b)(6) and the other on (b)(6).Doesn't see the message but when he looks at the rtps her gets unknown error.Inquired what led up to the complaint.Customer response: was at the orthodontist when the alert happened.First time having this issue since getting on the 670g and changed it that morning.By the time he got back to insulin flow blocked alarm during basal/bolus/fill cannula t/s per (b)(4).Expl insulin flow blocked alarm and possible causes.Adv to check pump's bolus speed setting.Customer is using standard.Item - 'advise customer to disconnect at the qr' reason not completed - past event.Item - 'assist customer in performing a 5.0u fill cannula' reason not completed - past event, currently on different set choses not to test.Customer states the insulin exited.Customer is able to remove set at this time to test site portion of inf.Adv to remove the set and examine the cannula.Customer states the cannula is bent.Adv to reset fill cannula to the appropriate cannula prime for their inf.Customer's outcome pertaining to the complaint: t/s moved to bent cannula.Ship: nothing / return: nothing.Initial notes: see above inquired what led up to the complaint.Customer response: see above high bg/under delivery t/s per (b)(4).Patient's bg at time of incident: 340 mg/dl.Patient's current bg: 160 mg/dl.Customer reports the following symptoms related to their high bgs: no.Will typically try not to change it at night, and he notices anytime he goes over the 2.5-3 day mark his bg go up.Customer reports they do not feel okay to t/s.Suggested calling hcp and following the guidelines outlined in the ifu, or seek medical attention and call back to t/s.Adv the symptoms they have expressed may be indicative of the possible onset of dka.Inquired if customer would like to stop now and contact their hcp, or if they wish to proceed.Customer response: stop.He waited a bit after he got home to see if his pump would recover, but then kept getting the ins flow blocked alert and then his bg began to rise rapidly.After he got the blocked cannula he changed his set and tried to remedy the situation.Explained the 2 high bg rule.Adv to change entire set, reservoir and insulin and treat per hcp's instructions.Adv to call back for assistance if hbgs persist.Explained the interaction aftercare email.Customer's outcome pertaining to the complaint: continue to insulin flow block t/s ship: nothing / return: nothing initial notes: see above inquired what led up to the complaint.Customer response: see above bent cannula troubleshooting per (b)(4).Customer reports the infusion set cannula is: bent.Site location: front (left) of abdomen/side (right) of abdomen inquired if customer stands upright when inserting infusion set.Found: standing inquired if customer has sufficient sub-q tissue where set is inserted.Found: very limited locations set insertion method used: serter inquired if customer experienced any issues with serter during use.Found: no inquired if customer has issues with scarred tissue, hardened tissue or stretch marks.Found: no when bent cannula occurred: noticed after removal after the alarm.Length of time infusion set has been in use: 3hrs (b)(6)/2.5hrs (b)(6) inquired if customer had any issues with tape not adhering.Found: none inquired if customer used any soaps, gels or lotions prior to inserting infusion set.Found: usually washes skin and takes 2 alcohol swabs to cleanse it.Wishes that there was a 4mm cannula adv an inf with a longer cannula may bend against muscle on lean customers.Adv an inf i go to record for full text.

• Brand Name: PARADIGM QUICK SET MMT-399T
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7526446
• MDR Text Key: 109003809
• Report Number: 2032227-2018-03494
• Device Sequence Number: 1
• Product Code: FPA
• 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: Patient
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-399T
• Device Catalogue Number: MMT-399T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 74