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

Model Number	MMT-522LNAS
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin pump passed rewind test, basic occlusion test, prime or compromised force sensor system test and displacement test.However, insulin pump received stuck in the motor error loop during bolus or basal delivery.The motor may have had an intermittent failure that was not detected during our testing.The motor was tested outside the device and passed.
Event or Problem Description
The customer reported via phone call that the insulin pump received motor error.The customer¿s blood glucose level was 300 mg/dl at the time of incident.The customer was assisted with troubleshooting.Customer reports the drive support cap was normal.Customer was able to complete insulin pump rewind.The customer was advised to discontinue the use of insulin pump and revert to backup plan.The device will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAS
• 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: 8747570
• Report Number: 2032227-2019-23183
• Device Sequence Number: 1668427
• Product Code: OYC
• UDI-Device Identifier: 00613994407696
• UDI-Public: (01)00613994407696
• 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): 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-522LNAS
• Device Catalogue Number: MMT-522LNAS
• Device Lot Number: A000114248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 91