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

Model Number	MMT-326A
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/12/2020
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that they were hospitalized due to low blood glucose on (b)(6) 2020 with blood glucose of 40 mg/dl.Customer has been using insulin pump system within 48 hours of reported low blood glucose event.The customer was treated with food.Customer stated that the drive support cap appeared normal.The customer reported that they did believe insulin pump was over-delivering.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Evaluated one open/used reservoir and checked o-rings/stopper groove for anomalies none were found.Ran basal bolus leaking test: reservoir filled with diluent and connected to a new infusion set, installed reservoirs and connectors into paradigm insulin pump.Conclusion: reservoir no occluded, not leak and did not continue dripping insulin after test.(b)(4).

• 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: 10166326
• Report Number: 2032227-2020-132717
• Device Sequence Number: 3467781
• Product Code: FRN
• UDI-Device Identifier: 00643169771437
• UDI-Public: (01)00643169771437(17)221029(10)HG3VV0K
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 07/14/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/29/2022
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG3VV0K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/14/2020
• 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: Hospitalization
• Patient Age: 74 YR
• Patient Weight: 142