MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number	MMT-332A
Medical Device Problem Codes	Obstruction of Flow (2423); Failure to Align (2522); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump had insulin flow blocked alarm.The troubleshooting was performed for the high blood glucose and insulin flow blocked alarm.The customer reported that event was resolved by reservoir change.No harm requiring medical intervention was reported.The reservoir will be returned for analysis.
Additional Manufacturer Narrative
Evaluated 1 open or used reservoir.Inspected reservoir, snap-cap, and septum for anomalies none were found.Ran occlusion test per (b)(4) as follows: reservoir filled with diluent and connected to a new infusion set, installed reservoir & connector into a paradigm pump.Performed a manual prime visual fluid flow through infusion set and out catheter tip.Conclusion: reservoir not occluded.No anomalies found to transfer guard during pre-fill.
Additional Manufacturer Narrative
Evaluated 1 open/used reservoir.Inspected reservoir, snap-cap, and septum for anomalies none were found.Ran occlusion test : reservoir filled with diluent and connected to a new infusion set, installed reservoir & connector into a paradigm insulin pump.Performed a manual prime and visual fluid flow through infusion set and out catheter tip.Conclusion: reservoir not occluded.No anomalies found to transfer guard during pre-fill.(b)(4).

• Brand Name: RESERVOIR 3ML MMT-332A
• 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: 9816384
• Report Number: 3004209178-2020-82951
• Device Sequence Number: 1367392
• Product Code: FRN
• UDI-Device Identifier: 00643169786547
• UDI-Public: (01)00643169786547(17)200813(10)HG206AC
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/13/2020
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG206AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/09/2020; 06/05/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/17/2020; 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 276