MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723NAH

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Hyperglycemia (1905)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer's relative reported via phone call that the customer was hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2018 with blood glucose of 650 mg/dl.The customer was treated with insulin drip.Customer 's relative reported that the customer's insulin pump buttons were hard to push and has been off the insulin pump since hospitalization.No significant event leading to keypad anomaly was observed and confirmed that the time was advancing.Customer's relative declined high blood glucose troubleshooting.The customer was wearing the insulin pump prior to hospitalization.Customer was discharged from the hospital on (b)(6) 2018.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.

Manufacturer Narrative

Insulin pump had unresponsive buttons at esc and act due to unlocked lcd keypad connector during visual inspection.Unable to perform rewind test, basic occlusion test, occlusion test, prime or compromised force sensor system alarm test, excessive no delivery test and displacement test due to unresponsive button.No button error alarm during testing.However, keypad flattened button dome switch was found on esc, act, up and down.Insulin pump received with minor scratched lcd window, cracked belt clip slot, stained end cap sticker, stained address or serial number label and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• 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
• MDR Report Key: 7293203
• MDR Text Key: 100830270
• Report Number: 3004209178-2018-52820
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169507227
• UDI-Public: (01)00643169507227
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: B5723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Date Manufacturer Received: 05/07/2018
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 123