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

Model Number MMT-551NAH

Device Problems Break (1069); Crack (1135); Component Missing (2306)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Pump was received with no button response due to flattened escape, act and up buttons dome switch.Inspected j2/lcd connector and no unlocked connector noted.Pump had cracked case at display window corner, battery tube threads, broken reservoir tube lip, missing reservoir tube o-ring and minor scratched display window.

Event Description

The customer reported via phone call that their insulin pump was damaged.The customer's blood glucose level was unknown at the time of the incident.The customer stated that the top part of the pump was cracked and a chunk is missing.The customer stated that blood was gushing everywhere because the pump fell off.The customer noticed the damage during site change.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.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: 6668473
• MDR Text Key: 78554896
• Report Number: 3004209178-2017-76391
• 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: 06/01/2017

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-551NAH
• Device Catalogue Number: MMT-551NAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/26/2017
• 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: 43 YR
• Patient Weight: 81