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

Model Number	MMT-522RNAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/17/2018
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.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 was reported via phone call that, the insulin pump had compromised force sensor system alert with prime rewind anomaly.The blood glucose was 458 mg/dl at the time of the incident.Customer stated that, they are unable to exit the preparing to prime loop.Customer stated that, the rewind message occurred after an alarm and the insulin was squirting out during the manual prime process.They are unable to describe any possible damage to the drive support cap.Customer treated the high blood glucose with manual injections with insulin.Troubleshooting determined that, the insulin pump should be replaced.The customer advised to discontinue use of the pump and revert to a back-up plan.The device will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522RNAB
• 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: 7303776
• Report Number: 2032227-2018-01693
• Device Sequence Number: 1328392
• Product Code: OYC
• UDI-Device Identifier: 00613994623553
• UDI-Public: (01)00613994623553
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

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-522RNAB
• Device Catalogue Number: MMT-522RNAB
• Device Lot Number: A000142708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2018
• Initial Report FDA Received Date: 02/28/2018
• 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: 62 YR
• Patient Weight: 182