MAUDE Adverse Event Report: MEDTRONIC MINIMED RESERVOIR MM640GT; PUMP, INFUSION

Model Number MMT-1031

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364); Polydipsia (2604)

Event Date 08/22/2022

Event Type  Injury  

Event Description

Information received by medtronic indicated that the customer insulin pump was under delivering because reservoir was leaking.Customer experienced high blood glucose level and was hospitalized.Blood glucose was 30.2 mmol/l and treated with insulin pen.Customer reported positive results in ketones test, nausea, vomiting, abdominal pain, difficulty breathing, very thirsty symptoms.The insulin pump will not be returned for analysis.

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.

• Brand Name: RESERVOIR MM640GT
• 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: 15310028
• MDR Text Key: 298769843
• Report Number: 2032227-2022-317267
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1031
• Device Catalogue Number: MMT-1031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2022
• 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 Outcome(s): Hospitalization; Other