MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723NAB

Device Problems Naturally Worn (2988); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with no button response due to corroded keypad traces.No button error alarm was noted during testing.The unit was unable to perform all functional testing including the displacement, operating currents, unexpected restart error, rewind, basic occlusion, occlusion, prime/compromised force sensor system, and excessive no delivery tests due to the buttons not responding.No moisture damage on the lcd board, mother board, interface board, radio frequency board, motor, vibrator, and motor and battery tube assemblies were noted during visual inspection.The following physical damage was noted: cracked casing at a display window corner, cracked reservoir tube lip, minor scratches on the lcd window, and cracked battery tube threads.(b)(4).

Event Description

The customer's mother reported via phone call that the insulin pump screen had large scratches that made the display difficult to read.The patient's blood glucose at the time of incident is unknown.The mother stated that the cause of the scratches were wear and tear.The display was also foggy.The insulin pump was returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6093368
• MDR Text Key: 60023319
• Report Number: 2032227-2016-41084
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAB
• Device Catalogue Number: MMT-723NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 15 YR
• Patient Weight: 71