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

Model Number	MMT-326A
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/03/2018
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 they were hospitalized due to high blood glucose on (b)(6) 2018 with blood glucose of over 300 mg/dl.Customer¿s other blood glucose level was 215 mg/dl at the time of call.Customer did not provide details regarding symptoms and treatment of their high blood glucose episodes.Customer also reported that the reservoir had air bubble anomaly.Customer stated that there was air bubble in the reservoir about 1/8 inch.Customer troubleshoot was not performed.The insulin pump will be returned for analysis 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
• MDR Report Key: 8145559
• Report Number: 2032227-2018-72646
• Device Sequence Number: 1502061
• Product Code: FRN
• UDI-Device Identifier: 00643169771413
• UDI-Public: (01)00643169771413(17)210531(10)HG2KUC3
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/09/2018

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: 05/31/2021
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG2KUC3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/10/2018
• 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-SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Weight: 59