MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-523LNAB

Device Problems Excess Flow or Over-Infusion (1311); Appropriate Term/Code Not Available (3191)

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 Description

It was reported that customer experienced low blood glucose of 20 mg/dl after bolusing for food on (b)(6) 2017.Customer became unconscious and fell to the ground causing injuries.The insulin pump had over delivered insulin.Customer was then hospitalized for eleven days and was admitted into a rehabilitation facility for months.It was reported that the infusion set used by customer was recalled days after customer was injured.Insulin pump is expected to return.

Manufacturer Narrative

Cracked display window, cracked case display window corner, cracked battery tube threads and cracked case reservoir tube window corner.Device did not have a battery installed when received.Test energizer alkaline battery 1.593 volts.Device passed the displacement test, rewind, basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test and delivery accuracy test at 0.08760 inches.No over delivery anomaly or under delivery anomaly noted.The stop current and run current measurement tests are within specification.Device also passed off no power alarm test and a21 error test.Device passed tone check on self test.Device failed vibrate check on self test, unable to determine root cause of the vibrate anomaly due to device preservation.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAB
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 9114261
• MDR Text Key: 160149598
• Report Number: 2032227-2019-67996
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513822
• UDI-Public: (01)00643169513822
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAB
• Device Catalogue Number: MMT-523LNAB
• Device Lot Number: A4523LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 258