MAUDE Adverse Event Report: MEDTRONIC MINIMED SURE T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-864

Device Problems Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on october 1, 2017.Subsequently, medtronic diabetes conducted a two year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone that they received a no delivery alarm.Customer's blood glucose level at the time of the incident was 182 mg/dl.Customer was able to troubleshoot.Customer reported that insulin did not exit when attempting to push it through with a plunger.Customer replaced the infusion set and observed insulin exit the tubing with the same reservoir.The product is not expected to be returned.On (b)(6) 2016 16:31:28 pst ice batch user (batch_ice) (b)(4).Complaint status: in process.(b)(6).(b)(6) reported that the customer received a no del alert several times, (b)(6) reported that the customer change reservoir 2-3 times per month.(b)(6) advised against it as reservoir should be changed with every infusion set change displacement verification test passed, the pump alarmed no reservoir the insulin does not exit with plunger push.Customer reconnected the tubing with reservoir but again the insulin did not exit with plunger push.Customer changed the entire infusion set and the pump prime 12u with fill tubing, (b)(6) asked to program additional 5u fixed prime the amount passed without a problem.(b)(6) asked to replace 6 infusion sets and 1 reservoir mmt-864,lot: 5138177, expiration date 01/2021; mmt-332a, lot: hgoqmjq, 10/2018 (b)(6).Input date: 06/22/2016 warranty start: 00/00/0000 warranty end: 00/00/0000 batch - 5138177.

• Brand Name: SURE T
• 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: 7201609
• MDR Text Key: 97919821
• Report Number: 2032227-2018-00754
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20643169441655
• UDI-Public: (01)20643169441655(017)20210101
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2021
• Device Model Number: MMT-864
• Device Catalogue Number: MMT-864
• Device Lot Number: 5138177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 01/17/2018
• Date Device Manufactured: 02/29/2016
• 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