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	08/19/2019
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.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
Customer called and reported that they experienced low blood glucose on (b)(6) 2019 with blood glucose of 75 mg/dl at the time of the incident.The customer used glucose tablets and food to treat.The customer did not mention any symptoms.The customer was wearing the insulin pump during the incident.The customer believes the pump was over delivering.Troubleshooting was completed but did not resolve the issue.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Evaluated 1 random seal reservoir and checked o-rings or stopper groove for anomalies none were found.Ran basal bolus leaking test as follow: reservoir filled with diluent and connected to a new infusion set, installed reservoirs and connectors into a paradigm pump.Conclusion: reservoir not leaks and no occluded.(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: 8940259
• Report Number: 2032227-2019-54289
• Device Sequence Number: 19343329
• Product Code: FRN
• UDI-Device Identifier: 00643169771413
• UDI-Public: (01)00643169771413(17)201210(10)HG26VUC
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/16/2019

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: 12/10/2020
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG26VUC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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: 38 YR
• Patient Weight: 109