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

Model Number	MMT-326A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/15/2020
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 call that the customer had high blood glucose level of 501 mg/dl.Customer was treated with manual injection.Customer experienced blood glucose levels of 449, 375, 306 and 72 mg/dl.Customer stated that the reservoir was leaking.Customer reports o-ring inside lip of reservoir compartment was not missing.Customer states there were no cracks in the pump.Customer did self test and it was passed.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Evaluated 1 open or used 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 paradigm pump.Conclusion: reservoir not leaks.Also performed a visual inspection and found no physical or cosmetic damage.(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: 10178211
• Report Number: 2032227-2020-134631
• Device Sequence Number: 19711355
• Product Code: FRN
• UDI-Device Identifier: 00643169771437
• UDI-Public: (01)00643169771437(17)200607(10)HG1VWX1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/01/2020

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: 06/07/2020
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG1VWX1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/01/2020
• 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: FRN MMT-326A, UNOMED MMT-399
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 170