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

Model Number MMT-551LNAS

Device Problems Break (1069); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

Event Date 01/21/2017

Event Type  malfunction  

Manufacturer Narrative

Was unable to perform displacement test due to completely broken reservoir tube lip.Unit received minor scratched display window, cracked case at display window corner, cracked belt clip slot, cracked battery tube threads, cracked reservoir tube window, cracked case at reservoir tube window corner, cracked display window and missing reservoir tube o-ring.

Event Description

Customer reported via phone call to have physical damage of insulin pump.Customer reported that reservoir rim broke off and o-ring came out.Customer's blood glucose was 160 mg/dl.Customer was advised that insulin pump would need to be replaced.

• 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: 6384803
• MDR Text Key: 69569808
• Report Number: 3004209178-2017-94383
• Device Sequence Number: 1
• Product Code: OYC
• 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: 01/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAS
• Device Catalogue Number: MMT-551LNAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2017
• Initial Date FDA Received: 03/07/2017
• 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 Age: 40 YR
• Patient Weight: 72