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

Model Number	MMT-722LNAL
Medical Device Problem Codes	Mechanical Problem (1384); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose/flush drive support disk.Unable to perform prime/a33 test, excessive no delivery test and occlusion test due to motor error alarm.(b)(4).
Event or Problem Description
The customer reported via phone call that they had a high blood glucose value of 571 mg/dl.Customer stated that the insulin pump had motor error.Customer was able to clear alarm.The device will be returned for analysis.Frn-unk-rsvr.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAL
• 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: 10256324
• Report Number: 2032227-2020-144443
• Device Sequence Number: 2623633
• Product Code: OYC
• UDI-Device Identifier: 00613994409539
• UDI-Public: (01)00613994409539
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/10/2020

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-722LNAL
• Device Catalogue Number: MMT-722LNAL
• Device Lot Number: A000114715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/10/2020
• 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: 63 YR
• Patient Weight: 200