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

Model Number MMT-723NAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Itching Sensation (1943); Rash (2033)

Event Date 02/12/2019

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone call that they experienced high blood glucose level of 500 mg/dl.Customer¿s current blood glucose level was 271 mg/dl.The customer feels ok to troubleshooting high blood glucose level.Customer reported that they did not contacted their health care professional regarding the high blood glucose event.The customer did not provide any symptoms regarding high blood glucose.The customer was treated for the high blood glucose with insulin shots.Customer stated that the air bubbles noticed on reservoir.Approximate size of air bubbles was 3/ 4 th inches.Customer also stated that the time and date was not correct.The drive support cap appears normal.Customer stated that the displacement test was passed.The customer was neither in the emergency room, nor admitted into hospital as a result of high blood glucose.Based on customer report customer does not allege insulin pump was under delivering.The insulin pump and reservoir was not returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
• 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: 8346788
• MDR Text Key: 136448254
• Report Number: 3004209178-2019-56623
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169507234
• UDI-Public: (01)00643169507234
• 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
• Report Date: 02/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAL
• Device Catalogue Number: MMT-723NAL
• Device Lot Number: B5723NALJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Date Device Manufactured: 01/04/2016
• 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: 70 YR
• Patient Weight: 193