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

Model Number MMT-523NAS

Device Problems Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Irritation (1941)

Event Date 01/12/2019

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.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.The customer¿s blood glucose level was 417 mg/dl at the time of the incident.Customer stated other blood glucose value was 500 mg/dl, 494 mg/dl, 457 mg/dl, 421 mg/dl, 347 mg/dl, 189 mg/dl, 486 mg/dl, 550 mg/dl, 498 mg/dl, 489 mg/dl, 511 mg/dl, 452 mg/dl, 484 mg/dl, 388 mg/dl, 552 mg/dl, 496 mg/dl, 389 mg/dl, 453 mg/dl, 412 mg/dl, 497 mg/dl, 547 mg/dl, 559 mg/dl, 437 mg/dl, 480 mg/dl, 482 mg/dl, 406 mg/dl, 436 mg/dl, 429 mg/dl, 557 mg/dl, 496 mg/dl, 521 mg/dl.Customer stated they experienced symptoms such as irritable and tired.Customer was treated with insulin pump and manual injection.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer allege insulin pump was under delivering.Customer stated drive support cap appears normal.Troubleshooting was performed.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS
• 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: 9340297
• MDR Text Key: 166932171
• Report Number: 2032227-2019-119554
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169202344
• UDI-Public: (01)00643169202344
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523NAS
• Device Catalogue Number: MMT-523NAS
• Device Lot Number: B1523NASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Date Device Manufactured: 12/16/2013
• 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-MMT-326,UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 86