MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 1.8ML MMT-326A; PUMP, INFUSION

Model Number MMT-326A

Device Problem Improper Flow or Infusion (2954)

Patient Problems Hyperglycemia (1905); Rash (2033)

Event Date 01/26/2020

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.(b)(4).

Event Description

The customer reported via phone call that they were experiencing high blood glucose.Blood glucose level was 426 mg/dl at time of incident.Customer reported that the infusion set caused redness on her skin.Customer does not allege insulin pump was under delivering.Customer had using insulin pump system within 48 hours of reported high blood glucose event and auto mode was inactive.Customer was neither in emergency room, nor admitted into hospital.Customer stated when removing the reservoir from insulin pump it had a large air bubble.The insulin pump will be returned for analysis.

• Brand Name: RESERVOIR 1.8ML MMT-326A
• 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: 9646207
• MDR Text Key: 176938734
• Report Number: 3004209178-2020-62097
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00643169771437
• UDI-Public: (01)00643169771437(17)220901(10)HG3PU35
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG3PU35
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2020
• Date Device Manufactured: 09/01/2019
• 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: FRN-MMT-326-RSVR, UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 95