MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP; OZO

Model Number MMT-551NAP

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Overdose (1988); Loss of consciousness (2418)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer reported via phone call that she recently had a blood glucose level of 20 mg/dl that was treated by paramedics.Customer stated that she lost consciousness prior to paramedics' response.The customer stated that she was transported to the hospital, where she was treated but not admitted.Customer stated that she was wearing the insulin pump at the time of the incident.The customer stated that she felt that the insulin pump was over-delivering.The insulin pump was replaced and was scheduled to be returned for analysis.

Manufacturer Narrative

The insulin pump received with the operating currents within specification and passed the self-test, unexpected restart error test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.No excessive no delivery alarms noted.A water filled reservoir was used during testing; observed liquid exit the tubing during the bolus deliveries.All boluses delivered properly and were listed in the bolus history screen.No delivery anomalies noted during testing.The insulin pump passed the displacement accuracy test.The insulin pump was received with cracked reservoir tube lip, cracked battery tube threads, case cracked at the display window corner, minor scratched lcd window, and scratched reservoir tube window.

• Brand Name: 530G INSULIN PUMP
• Type of Device: OZO
• 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: 6250286
• MDR Text Key: 64770726
• Report Number: 3004209178-2017-83684
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• 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: 64 YR
• Patient Weight: 60