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)

Event Date 09/14/2020

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

It was reported that the customer experienced hypoglycemia.The customer blood glucose level was 32 mg/dl.Customer stated that she had seizure today and mostly sleeping the whole day.Customer had symptoms such as mental confusion and belligerence numbness of face.The customer was assisted with troubleshooting.The customer was treated with food and glucose tablets other glucagon for low blood glucose.Customer was using insulin pump system within 48 hours of reported low blood glucose event.Customer stated that they did alleging insulin pump for over delivery, because they had low while pump was suspended.Customer stated that drive support cap was normal.Customer was offered troubleshooting for battery issues and declined for battery issue.The insulin pump will be returned 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: 10598973
• MDR Text Key: 208917689
• Report Number: 2032227-2020-183823
• 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: consumer
• Type of Report: Initial
• Report Date: 09/29/2020

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?: Yes
• 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: 09/18/2020
• Initial Date FDA Received: 09/29/2020
• 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 SET
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 130