MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-943T MIO 2PK 6MM 23IN BLUE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-943T

Device Problems Bent (1059); Loose or Intermittent Connection (1371)

Patient Problem Hyperglycemia (1905)

Event Date 06/25/2017

Event Type  Injury  

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.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 were experiencing issues with their infusion sets.One had a bent cannula and one infusion set would not stay attached.The customer also reported that their blood glucose level was over 600 mg/dl.It would not register on the meter.They treated their high blood glucose with the insulin pump.The customer¿s current blood glucose level was 171 mg/dl.Troubleshooting was performed on the insulin pump.The infusion set is expected to be returned for analysis.

• Brand Name: INFST MMT-943T MIO 2PK 6MM 23IN BLUE
• 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: 6980642
• MDR Text Key: 90349877
• Report Number: 2032227-2017-61875
• 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: 10/26/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2019
• Device Model Number: MMT-943T
• Device Catalogue Number: MMT-943T
• Device Lot Number: 5165209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 10/26/2017
• 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: 44 YR
• Patient Weight: 104