MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAH
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The insulin pump was received with partially broken off piece at the reservoir tube lip.However, the pcap / reservoir locked properly during testing.The insulin pump was received with all operating currents within spec and passed the rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, self test and displacement test.Pump passed the delivery accuracy test at 0.08770 inches.The insulin pump alarmed unexpected restart after battery installation due to interface board leaking voltage.The insulin pump was received with broken off piece at the battery tube threads.
Event or Problem Description
The customer called to report high blood glucose of over 600 mg/dl and required medical intervention.Troubleshooting was not completed.The customer also reported that the insulin pump had cracks on the reservoir and battery compartment.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH
• 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: 7745517
• Report Number: 2032227-2018-08920
• Device Sequence Number: 1588536
• Product Code: OYC
• UDI-Device Identifier: 00643169221529
• UDI-Public: (01)00643169221529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/02/2018

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-523RNAH
• Device Catalogue Number: MMT-523RNAH
• Device Lot Number: A000291727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 08/02/2018
• 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: Hospitalization
• Patient Age: 63 YR
• Patient Weight: 151