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

Model Number	MMT-326A
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported via phone call that customer was hospitalized due to high blood glucose on (b)(6) 2020 with blood glucose of 219 mg/dl.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer treated with injections.Customer stated they contact their health care professional regarding high blood glucose.Based on customer report customer did allege insulin pump was under delivering.Customer stated reservoir had air bubbles noticed during therapy.The insulin pump will and reservoir will not be returned for analysis.

• Brand Name: RESERVOIR 1.8ML MMT-326A
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 10217114
• Report Number: 2032227-2020-139747
• Device Sequence Number: 11363904
• Product Code: FRN
• UDI-Device Identifier: 00643169771437
• UDI-Public: (01)00643169771437(17)221110(10)HG3U0Z3
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/10/2022
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG3U0Z3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNOMED INF SET.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Weight: 67