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

Model Number	MMT-722LNAB
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/20/2019
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 reported via phone call that the customer was hospitalized due to high blood glucose level was over 600 mg/dl at the time of the incident.The customer other blood glucose was 300 mg/dl.The customer was hospitalized on (b)(6) 2019.The customer was treated with insulin.Customer also stated that the insulin was leaking in the pump as well as insulin pump was exposed to fluid in the past with no moisture visible in pump.Troubleshooting was performed.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test.The stop (idle) current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.The no delivery alarm functions properly during the basic occlusion test and occlusion test.No unexpected no delivery alarm noted during testing.Device responded properly to button presses.No unresponsive buttons or button error alarm noted.No damage noted on the keypad traces.Device uploaded properly using carelink.Device had minor scratched display window, cracked case at display window corner, cracked battery tube threads, scratched reservoir tube window, stained end cap sticker and a partially broken off reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.During visual inspection, the motor and electronic assembly had moisture damage.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAB
• 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: 9393651
• Report Number: 2032227-2019-125790
• Device Sequence Number: 16253090
• Product Code: OYC
• UDI-Device Identifier: 00613994409522
• UDI-Public: (01)00613994409522
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 12/12/2019

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-722LNAB
• Device Catalogue Number: MMT-722LNAB
• Device Lot Number: A000114649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNOMED SET.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 58 YR
• Patient Weight: 98