MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-751LNAH

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 03/26/2017

Event Type  Injury  

Manufacturer Narrative

The insulin pump passed the functional test, including the displacement test, rewind, and basic occlusion test, and occlusion test, prime test, excessive no delivery test and dat test at 0.08790 inches.The pump communicated properly with the glucoses sensor simulator and the minilink transmitter.No sensor anomaly noted.The pump had minor scratched display window above the act button and cracked reservoir tube lip.

Event Description

The customer reported via phone call that they were hospitalized due to high blood glucose on (b)(6) 2017 with blood glucose of 538 mg/dl.The customer was hospitalized for diabetic ketoacidosis.The customer was on bed rest due to hip dislocation.The customer treated with manual injections and 3 set changes and reservoirs.The customer was wearing the insulin pump during the hospitalization.The customer stated that the pump was damaged.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• 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: 6528062
• MDR Text Key: 73895581
• Report Number: 3004209178-2017-49345
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P120010
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAH
• Device Catalogue Number: MMT-751LNAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/27/2017
• 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): Hospitalization; Other
• Patient Age: 43 YR
• Patient Weight: 83