MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723LNAS

Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)

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

Event Date 12/30/2013

Event Type  malfunction  

Manufacturer Narrative

The insulin pump passed the displacement test, self test, unexpected restart error test and basic occlusion test.All operating currents are within specification.Off no power alarm functioned properly.No motor error alarm noted during testing.The insulin pump was unable to prime during prime test due to faulty force sensor resistor.Analysis was unable to perform the occlusion test and excessive no delivery test due to prime and fill anomaly.The motor passed motor test.The insulin pump had a scratched display window, cracked battery tube threads, cracked reservoir tube, cracked reservoir tube lip and a missing end cap sticker.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.

Event Description

The customer reported via phone call that they received a motor error alarm and no delivery alarm.The customer's blood glucose was 112 mg/dl at the time of incident.The customer stated that the drive support cap appeared normal.The customer stated that they were able to rewind the insulin pump.The customer stated that the insulin pump was exposed to airport scanners.The customer performed self test and the insulin pump passed.The customer declined to troubleshoot for no delivery alarm.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• 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: 5987600
• MDR Text Key: 56372813
• Report Number: 2032227-2016-22551
• 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: 12/30/2013

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-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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: 49 YR
• Patient Weight: 75