MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number MMT-332A

Device Problems Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)

Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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's mother reported via phone call that her daughter's insulin pump was over delivering the insulin and her daughter was admitted to the hospital on (b)(6) 2020 due to hypoglycemia.Customer did not use auto mode feature at the time of reported high blood glucose.Blood glucose level at the time of hospitalization was 40 mg/dl.Customer's blood glucose dropped and she passed out and also had seizure due to it she ran to the hospital.Customer was in emergency room.Customer was treated with glucose tablet and glucagon shots and pen.Customer ahd been using insulin pump system within 48 hours of reported high blood glucose event.Customer's mother said they noticed that the insulin pump gave a bolus of 10 units that they did not administer or deliver, said it was showing on the history of the insulin pump on that day.Insulin pump will be and reservoir will not be returned for analysis.

• Brand Name: RESERVOIR 3ML MMT-332A
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10177330
• MDR Text Key: 195894659
• Report Number: 2032227-2020-134063
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/21/2020

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 Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/21/2020
• 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
• Treatment: UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR
• Patient Weight: 54