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

Model Number MMT-751NAP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Tingling (2171)

Event Date 05/23/2014

Event Type  malfunction  

Manufacturer Narrative

The insulin pump passed displacement test, rewind, basic occlusion, occlusion, prime, and excessive no delivery alarm test.The pump functioned properly.The pump had intermittent button response noted during testing due to moisture damage on keypad traces.The pump was received with scratched lcd window, cracked reservoir tube lip, and cracked battery tube threads.(b)(4).

Event Description

The customer reported via phone call that the pump had a keypad anomaly and high blood glucose.The blood glucose at the time of the incident was 176 mg/dl.The customer had symptoms such as tingling mouth, and nausea.The customer did not contact their healthcare professional, but do have a backup plan; manual injections.The drive support cap appeared normal.Troubleshooting was started, however the pump stopped responding.Troubleshooting was not able to resolve the issue.The device will be returned 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6121309
• MDR Text Key: 60933572
• Report Number: 2032227-2016-37002
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2014
• 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: 47 YR
• Patient Weight: 91