MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522LNAB
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hyperglycemia (1905); Nausea (1970)
Date of Event	03/23/2019
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
The customer reported via phone call that they experienced high blood glucose level as well as alleging possible insulin pump was under delivery.Customer¿s blood glucose level was 594 mg/dl at the time of incident and current blood glucose level was 460 mg/dl and 290 mg/dl before the ending the call.The customer provides details on symptoms related to the high blood glucose level episodes such as nausea and abdominal pain.Customer was treated with insulin pump manual injection.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer stated that the drive support cap was normal.Customer stated that the cannula was bent.Customer declined to check for the presence of leaks or air bubbles in the tubing or reservoir.Troubleshooting was performed for high blood glucose level and under delivery.The device will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAB
• 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: 8463112
• Report Number: 2032227-2019-02672
• Device Sequence Number: 1288471
• Product Code: OYC
• UDI-Device Identifier: 00613994407726
• UDI-Public: (01)00613994407726
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/28/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-522LNAB
• Device Catalogue Number: MMT-522LNAB
• Device Lot Number: A000114252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2019
• Initial Report FDA Received Date: 03/29/2019
• 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: 52 YR
• Patient Weight: 79