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

Model Number	MMT-332A
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/10/2020
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
Customer reported via phone call that they had experienced hyperglycemia with blood glucose level of 300 mg/dl to 400 mg/dl.Customer was assisted with troubleshooting for high blood glucose level.Customer has been using insulin pump system within 48 hours of reported high blood glucose level.Customer was treated with bolus for high blood glucose level.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose level.Customer did allege insulin pump was under delivering as she smelled insulin.Customer stated that insulin pump had passed the high performance test.The insulin pump and the reservoir will be returned for analysis.
Additional Manufacturer Narrative
Evaluated 1 random open or seal reservoir.Inspected reservoir's o-rings or stopper groove for anomalies.None were found.Ran basal, bolus leaking test per dop114-811 as follows: reservoir filled with diluent and connected to a new infusion set.Installed reservoir and connector into a paradigm pump.Conclusion: reservoir no air bubbles and no leaking anomaly.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.

• 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: 9980175
• Report Number: 2032227-2020-106716
• Device Sequence Number: 3676190
• Product Code: FRN
• UDI-Device Identifier: 00643169786547
• UDI-Public: (01)00643169786547(17)210511(10)HG2JBW2
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/07/2020

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: 05/11/2021
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG2JBW2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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: UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Weight: 177