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

Model Number MMT-751NAP

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

Unit functioned properly during functional check including rewind and basic occlusion, occlusion, prime/compromised force sensor system, excessive no delivery, displacement, self-test, unexpected restart test, and all operating current measurement were normal.No unexpected low battery, weak battery, battery out off limit, or off no power alarm noted.Insulin pump was received with minor scratched display window, cracked case at display window corners, and cracked reservoir tube lip.

Event Description

The customer reported via phone call that the insulin pump alarmed weak battery and battery out limit.Customer's blood glucose level dropped to 46 mg/dl.He treated his blood glucose level with orange juice.He did not eat enough the night before and gave himself too much insulin.The insulin pump was working fine.The insulin pump alarmed battery out limit again after troubleshooting.Customer was advised to discontinue use of the device and revert to backup plan.The customer was advised that the device would be replaced and agreed to return the product for analysis.

• 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: 6362836
• MDR Text Key: 68465710
• Report Number: 3004209178-2017-92576
• 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
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• 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): Other
• Patient Age: 56 YR
• Patient Weight: 91