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

Model Number MMT-523LNAP

Device Problems Break (1069); Component Falling (1105); Positioning Problem (3009)

Patient Problem Hyperglycemia (1905)

Event Date 03/26/2017

Event Type  malfunction  

Manufacturer Narrative

The insulin pump had cracked case at display window corner, cracked battery tube threads, cracked reservoir tube, minor scratched display window, and reservoir tube lip completely broken off and test reservoir will not lock/click in place and.The device passed the operating currents measurement, self-test, unexpected restart error test, displacement test, prime and excessive no delivery test.The occlusion test and basic occlusion test could not be performed due to broken reservoir tube lip.

Event Description

The customer reported via phone call that the insulin pump had a broken reservoir tube lip.The customer stated that the reservoir would not stay inside the insulin pump and he was holding it with tape.Blood glucose level at the time of the incident was 281 mg/dl.Troubleshooting was performed.The customer stated that he was playing a sport and the insulin pump fell off a few times.It was advised to discontinue the use of the insulin pump and to revert to a back-up plan.The device 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 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: 6588852
• MDR Text Key: 76029586
• Report Number: 3004209178-2017-70882
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAP
• Device Catalogue Number: MMT-523LNAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2017
• 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 Age: 68 YR
• Patient Weight: 54