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

Model Number MMT-551NAH

Device Problem Failure to Prime (1492)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Unspecified Infection (1930); Nausea (1970); Neuropathy (1983); Pain (1994); Urinary Frequency (2275)

Event Date 11/23/2015

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.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.

Event Description

The customer experienced a high blood glucose level of over 600 mg/dl.She believed her high blood glucose level was due to her leg infection but the insulin pump did not help bring her blood glucose down.The customer had abdominal pain, was dehydrated, nauseous, urinated often, and has neuropathy.The customer was hospitalized on (b)(6) 2015 due to her high blood glucose level.She treated her high blood glucose level with needle injections.The customer was wearing the insulin pump at the time of the emergency room visit.It was becoming more difficult to prime.The customer was advised that the device would be replaced and agreed to return the product for analysis.

Manufacturer Narrative

The pump passed the functional testing including the displacement, rewind, basic occlusion, occlusion, prime, and excessive no delivery alarm tests.The pump functioned properly.The pump was received with intermittent button response during testing due to a flattened dome switch on the esc and act buttons.The pump was also received with minor scratches on the lcd window, a cracked reservoir tube lip, a cracked belt clip slot, and cracked battery tube threads.The keypad lcd connector was inspected and no anomaly was noted.

• 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: 5290007
• MDR Text Key: 33300533
• Report Number: 2032227-2015-73672
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• 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: 50 YR
• Patient Weight: 58