MAUDE Adverse Event Report: MEDTRONIC MINIMED RESERVOIR 3ML; PUMP, INFUSION

Model Number MMT-XXX

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Coma (2417)

Event Date 02/22/2022

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they were hospitalized due to high and low blood glucose on unknown date.Customer stated that the insulin pump was possibly over or under delivering.No further patient complications were reported.The customer will discontinue use of the device.

• Brand Name: RESERVOIR 3ML
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 13617012
• MDR Text Key: 287423214
• Report Number: 2032227-2022-118603
• Device Sequence Number: 1
• Product Code: FRN
• 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
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2022
• 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: UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 79 KG