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

Model Number MMT-551NAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Twiddlers Syndrome (2114); Diabetic Ketoacidosis (2364); Cognitive Changes (2551)

Event Date 10/19/2016

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.(b)(4).

Event Description

It was reported via phone call that customer was hospitalized on (b)(6) 2016 with blood glucose of 786 mg/dl.Customer had symptom of high blood glucose; customer was vomiting, dehydrated and not mentally well.Customer was hospitalized due to diabetic ketoacidosis.Customer was wearing insulin pump at the time of hospitalization.Troubleshooting could not be performed due to customer not having supplies.Tubing clamp would be sent in order to complete high pressure test.

Manufacturer Narrative

The insulin pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No excessive no delivery alarm noted.The insulin pump was received with cracked reservoir tube lip, stained end cap sticker and minor scratched lcd 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6065486
• MDR Text Key: 58711157
• Report Number: 2032227-2016-38349
• 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: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAL
• Device Catalogue Number: MMT-551NAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2016
• 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): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 57