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

Model Number MMT-551NAB

Device Problems Crack (1135); Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Vertigo (2134); Visual Disturbances (2140); Alteration In Body Temperature (2682)

Event Date 12/28/2014

Event Type  Injury  

Manufacturer Narrative

Pump passed all functional testing including the displacement, rewind, basic occlusion, occlusion, prime/delivery and excessive no delivery test; the displacement test functioning properly.Motor passed motor test.Pump received with cracked case at the display window corner, cracked reservoir tube lip and minor scratched lcd window.(b)(4).

Event Description

Customer reported via phone call to have been hospitalized on (b)(6) 2014 and again on (b)(6) 2014 with blood glucose of 600 mg/dl.Customer had symptom of a slight temperature, vertigo, and visual distortion.Customer was hospitalized due to a slight bladder infection.On both occasions, customer was released the next morning when blood glucose lowered.Customer was treated with insulin drip and iv.Customer was wearing insulin pump at the time of hospitalization.During troubleshooting, it was found that battery cap was cracked, time and date were incorrect and a no delivery alarm was received.Insulin pump passed high pressure test.Customer was advised that insulin pump would be replaced due to physical damage.

• 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: 5065702
• MDR Text Key: 25333271
• Report Number: 2032227-2015-41501
• 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
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAB
• Device Catalogue Number: MMT-551NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• 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: 73 YR
• Patient Weight: 92