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

Model Number	MMT-326A
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
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 by the customer's parent that the customer experienced low blood glucose on (b)(6) 2018 with blood glucose of 84 mg/dl at the time of the incident.The caller noticed in the bolus history that the customer was getting a bolus every half hour.The customer was at 59 mg/dl at the time of the call.The customer used food to treat.The caller did not mention any symptoms.The customer was wearing the insulin pump during the incident.The customer reported several un-programmed boluses.Troubleshooting was completed but did not resolve the issue.The caller also reported an issue with their meter display.The insulin pump will be returned for analysis.
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.The customer's weight information with the initial report was incorrect.The correct information has been included with this report.
Event or Problem Description
The customer's weight information with the initial report was incorrect.The correct information has been included with this report.

• 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: 8099320
• Report Number: 2032227-2018-65421
• Device Sequence Number: 11221019
• Product Code: FRN
• UDI-Device Identifier: 00643169771413
• UDI-Public: (01)00643169771413(17)210211(10)HG2BCC2
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/06/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/11/2021
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG2BCC2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2018
• Supplement Date Received by Manufacturer: 11/18/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 12/06/2018
• 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: Other
• Patient Age: 10 YR
• Patient Weight: 50