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

Model Number	MMT-332A
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/31/2020
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 the customer experienced high blood glucose levels.The customer¿s blood glucose level was 564 mg/dl.The customer had been using insulin pump system within 48 hours of reported high blood glucose event.The customer reported that they treated high blood glucose level with insulin pump.The customer reported that they experienced fatigue.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical services dispatched as a result of high blood glucose.The customer alleged the insulin pump for under delivery because they already switched sites but she was still having the same issue.The insulin pump was not on auto mode at the time of the incident.The insulin pump will not be returned for analysis.

• Brand Name: RESERVOIR 3ML MMT-332A
• 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: 10372317
• Report Number: 2032227-2020-158873
• Device Sequence Number: 3669396
• Product Code: FRN
• UDI-Device Identifier: 20763000273358
• UDI-Public: (01)20763000273358(17)230209(10)HG43E02
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/06/2020

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: 02/09/2023
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG43E02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 175