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

Model Number	MMT-326A
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/07/2020
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
It was reported that the customer experienced high blood glucose as well as insulin pump had an under delivery alarm.Customer's blood glucose value was 25 mmol/l at the time of the incident.Customer stated that the blood glucose value was rises after one hour of insulin and the value was 27 mmol/l.The customer used the insulin pump and manual injections to treat.The customer did not mention any symptoms.The customer was wearing the insulin pump during the incident.Customer was alleging the insulin pump for under delivery because the blood glucose remains high after bolusing and changing set.Troubleshooting was completed but did not resolve the issue.The 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: 10060620
• Report Number: 2032227-2020-118387
• Device Sequence Number: 3573132
• Product Code: FRN
• UDI-Device Identifier: 20763000273334
• UDI-Public: (01)20763000273334(17)230302(10)HG45597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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: 03/02/2023
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG45597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2020
• Initial Report FDA Received Date: 05/15/2020
• 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: Other