MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722LNAL
Medical Device Problem Codes	Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/25/2019
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 experienced high blood glucose.Customer¿s blood glucose level was 400 mg/dl.Customer had a problem with the plunger on the back of the reservoir that was sticking out, stated that there were a crack around the reservoir window, 3 to 4 of an inch by the reservoir compartment and drive support cap.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device pass displacement test.Device received with cracked reservoir tube window, cracked case from reservoir tube window corners and cracked reservoir tube lip.The drive support disk was inspected and found loose/protruded.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9840712
• Report Number: 2032227-2020-101836
• Device Sequence Number: 765018
• Product Code: OYC
• UDI-Device Identifier: 00613994409539
• UDI-Public: (01)00613994409539
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/24/2020

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 Model Number: MMT-722LNAL
• Device Catalogue Number: MMT-722LNAL
• Device Lot Number: A000114715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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: Other
• Patient Age: 59 YR
• Patient Weight: 68