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

Model Number MMT-523LNAB

Device Problems Out-Of-Box Failure (2311); Low Test Results (2458)

Patient Problem Hypoglycemia (1912)

Event Date 11/22/2016

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 spouse reported via phone call that the customer had been experiencing low blood glucose.She stated that a month back his blood glucose would not come back up and she had to call the ambulance.Blood glucose was 47 mg/dl; he was treated with glucose liquid and was not taken to the hospital.She also reported that during the current week there had been 5 times that his blood glucose level would drop and she almost had to take him to the hospital.Blood glucose on monday (b)(6) 2016 was 51 mg/dl; 49 mg/dl on tuesday (b)(6) 2016 and 40 mg/dl the morning of the call.Spouse stated that it seemed like the insulin pump had been over delivering insulin.Troubleshooting was performed and found the daily totals, basal history, bolus history and settings were accurate and the customer was not connected during prime.It was advised to discontinue the use of the insulin pump and revert to a back-up plan.The device was returned for analysis.

Manufacturer Narrative

The insulin pump passed functional testing including displacement test, rewind, basic occlusion, occlusion, prime and excessive no delivery alarm test.No delivery anomaly noted during testing.The insulin pump functioned properly.The insulin pump passed the displacement accuracy test.The insulin pump was received with cracked reservoir tube lip.

• 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 PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6264064
• MDR Text Key: 65306356
• Report Number: 3004209178-2017-84853
• 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,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAB
• Device Catalogue Number: MMT-523LNAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Initial Date Manufacturer Received: 12/22/2016
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 98