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

Model Number MMT-751NAS

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339); Date/Time-Related Software Problem (2582)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Nausea (1970); Overdose (1988); Seizures (2063); Vomiting (2144)

Event Date 07/01/2016

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.

Event Description

The customer reported via phone call that they were hospitalized due to low blood glucose.The customer reported that they had a seizure.The customer reported that the insulin pump was over delivering.The customer reported that the date kept going off.The customer's blood glucose was 60 mg/dl at the time of incident.The customer's blood glucose was 289 mg/dl at the time of call.The customer stated that they treated the low blood glucose with glucose tablets.The customer stated that they had nausea and they were vomiting.The customer stated that they were wearing the insulin pump during hospitalization.The customer stated that the insulin pump gave insulin without being programmed.The customer stated that there were no accidental button presses.The customer stated that the drive support cap appeared normal.The customer stated that the insulin pump was not exposed to high magnetic fields.The insulin pump will be returned for analysis.

Manufacturer Narrative

The insulin pump passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test.The insulin pump was programmed with the correct time/date and monitored.No time loss/gain noted or unexpected bolus delivery noted.The insulin pump was programmed with multiple test boluses and monitored.All boluses delivered properly and were listed in the bolus history screen.No delivery anomaly or history anomaly noted during testing.There is no data available due to the device returning with battery.We were unable to verify if the customer manually programmed unexpected boluses of 12 units, 5 units and another 5 units.No cosmetic damage noted.

Manufacturer Narrative

Additional information was received which was not included with the initial report.The information has been provided with this report.The insulin pump passed the delivery accuracy test.The motor was tested outside of the device and passed.

Manufacturer Narrative

Additional information has been provided by failure analysis that was not included on the initial device evaluation.The insulin pump motor was tested outside of the device and passed.The insulin pump passed the delivery volume accuracy test.

• 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 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: 5782602
• MDR Text Key: 49179512
• Report Number: 3004209178-2016-60044
• 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,Followup,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2016
• 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: 46 YR
• Patient Weight: 86