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

Model Number MMT-551LNAS

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 10/11/2016

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.(b)(4).

Event Description

The customer reported via phone call that her insulin pump over-delivered without her input, which caused her to go to the hospital for hypoglycemia.The patient's blood glucose at the time of hospitalization was 65 mg/dl.The patient was treated with 3 vials of d50.Troubleshooting was initiated for the insulin pump.The drive support cap appeared normal.The device programming was accurate as well.However, the customer maintained that the insulin pump over-delivered on its own.The customer was advised to discontinue use of the insulin pump.The insulin pump will be returned for analysis.

Manufacturer Narrative

The insulin pump passed functional testing including the displacement test, rewind, basic occlusion test, occlusion test, prime test and excessive no delivery test.The reservoir volume matches the units remaining in the status screen.The insulin pump was programmed with multiple boluses and monitored; all boluses delivered properly and were listed in the bolus history screen.The insulin pump was programmed with a 2.0 unit fill cannula; the insulin pump properly delivered the 2.0 unit fill cannula.The insulin pump was programmed with a basal profile and monitored.The basal profile delivered the indicated amount and was verified in the daily total screen.No bolus anomaly or basal anomaly noted during our testing.The insulin pump had minor scratched display window and cracked reservoir tube lip.

Manufacturer Narrative

The 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 MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6035600
• MDR Text Key: 57684808
• Report Number: 2032227-2016-32373
• 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
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAS
• Device Catalogue Number: MMT-551LNAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2016
• 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: 57 YR
• Patient Weight: 67