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

Model Number MMT-751NAB

Device Problems Premature Discharge of Battery (1057); Excess Flow or Over-Infusion (1311); Self-Activation or Keying (1557); Sticking (1597)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 06/16/2016

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 the keypad on his insulin pump was sticking, and when he tried to program a basal rate of 1.4 his menu scrolled all the way up to 30; this has happened several times.The patient's blood glucose at the time of incident is unknown.The customer did not recall any significant events leading to the keypad issues.The customer also mentioned that the insulin pump was over-delivering for the past two nights, and he has been waking up in the morning with blood glucose values in the 30 mg/dl range.The customer stated that the batteries deplete quickly and that the insulin pump buzzes on its own.Troubleshooting was initiated for the delivery anomaly and the basal rate profile appeared to be accurate.A displacement test was performed and the device passed.The customer was advised that the insulin pump was operating as designed, although the customer disagrees with that assessment.The insulin pump will be returned for analysis.

Manufacturer Narrative

All operating currents are within specification.No unexpected low battery or off no power alarms noted.The insulin pump passed functional test including displacement test, rewind, basic occlusion, occlusion, prime and excessive no delivery alarm test.The insulin pump functioned properly; the max basal rate scrolled lower than 1.4u hour successfully, the max basal rate functioning properly during testing.No basal or delivery anomaly noted.All buttons are functioning properly.No damage was found on the keypad traces noted during our visual inspection.The insulin pump was received with cracked case on the display window corners, minor scratched lcd window and cracked reservoir tube lip.

Manufacturer Narrative

The pump passed the delivery volume accuracy test.The motor was tested outside of the device and it passed.No motor error alarm or anomalies noted during testing.The lcd connector was inspected and no anomalies were 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 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: 5745954
• MDR Text Key: 48070097
• Report Number: 3004209178-2016-55058
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• 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): Other
• Patient Age: 52 YR
• Patient Weight: 73