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

Model Number	MMT-722NAS
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pump was received with motor error alarm during rewinding due to jammed motor gearbox.Unable to perform functional testings including displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test or verify a33 error alarm due to motor error alarm.Unit was received with missing motor/drive support disk, missing end cap sticker, detached end cap, cracked case at display window corner, minor scratched lcd window, broken belt clip slot at battery tube threads area and partially broken reservoir tube lip.
Event or Problem Description
Customer called and reported that they got admitted to a hospital due to low blood glucose on (b)(6) 2017 with blood glucose below 20 mg/dl at the time of the incident.The customer was experiencing a motor error alarm and a compromised force sensor system alarm 1 to 10 days after the pump was dropped.The pump's casing popped off on the motor side.The customer was given intravenous fluids and food to treat.The customer experienced symptoms such as a seizure.The customer was wearing the insulin pump during the incident.Troubleshooting was completed for the compromised force sensor system alarm.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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: 6675359
• Report Number: 2032227-2017-24517
• Device Sequence Number: 13968120
• Product Code: OYC
• UDI-Device Identifier: 00613994223746
• UDI-Public: (01)00613994223746
• 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: Patient
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

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-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A000093830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 158