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

Model Number	MMT-722LNAP
Medical Device Problem Codes	Failure to Cycle (1142); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/29/2019
Type of Reportable Event	Serious Injury
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Customer called and reported that they received emergency medical assistance due to low blood glucose on (b)(6) 2019 with blood glucose levels in the 30 mg/dl range at the time of the incident.The customer used food and was given glucose to treat.The customer did not mention any symptoms.The customer was wearing the insulin pump during the incident.The customer reported their pump drive support cap was protruded.Troubleshooting was not completed.The insulin pump will be returned for analysis on a different case.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAP
• 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: 9630768
• Report Number: 2032227-2020-100728
• Device Sequence Number: 17005569
• Product Code: OYC
• UDI-Device Identifier: 00613994409546
• UDI-Public: (01)00613994409546
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 01/26/2020

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-722LNAP
• Device Catalogue Number: MMT-722LNAP
• Device Lot Number: A000114634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/27/2020
• 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-332-RSVRUNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Weight: 240