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

Model Number MMT-523RNAS

Device Problems Connection Problem (2900); Patient Device Interaction Problem (4001)

Patient Problems Hyperglycemia (1905); Chills (2191)

Event Date 05/13/2019

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

The customer reported via phone call that the customer was hospitalized due to hyperglycemia on (b)(6) 2019 and the top of the reservoir where it goes was broken.The customer¿s blood glucose level was 404 mg/dl and 387 mg/dl.The customer reported that the reservoir lip ring was damaged.The customer also reported other event such as cold and shaky.The customer was treated with intravenous insulin and saline.The customer reported that the reservoir was not able to lock in place.The customer was advised to discontinue the use of insulin pump and revert to back up.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the rewind test, prime test and excessive no delivery 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.Unable to perform the displacement test, basic occlusion test, occlusion test and delivery accuracy test due to completely broken off reservoir tube lip.Unable to verify the no delivery alarm during the basic occlusion test and on the occlusion test due to completely broken off reservoir tube lip.No unexpected no delivery alarm note during the excessive no delivery test.The test p-cap and reservoir will not lock in place in the reservoir compartment due to completely broken off reservoir tube lip.Device also had a missing reservoir tube o ring, minor scratched display window, cracked battery tube threads, cracked case at the reservoir tube window corners and cracked reservoir tube window.Device uploaded properly using carelink.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• 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: 8685942
• MDR Text Key: 147560204
• Report Number: 2032227-2019-14264
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513099
• UDI-Public: (01)00643169513099
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A1523RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2015
• 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
• Treatment: FRN-UNK-RSVR, UNOMED SET
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 134