MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751LNAB

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Polydipsia (2604)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

All operating currents are within specification.No unexpected low batt or off no power alarms noted.Unit functioned properly.Unit passed functional test including displacement test, rewind, basic occlusion, occlusion, prime/a33, and excessive no delivery alarm test.Unit functioned properly.Unit received with intermittent button response during testing due to flattened dome switch on the up arrow button, down arrow button, esc and act buttons.J2 lcd connector was inspected and no anomaly was noted.Unit received with cracked case on display window corners, minor scratched lcd window, cracked reservoir tube lip and cracked battery tube threads.

Event Description

The customer reported via phone call that they were hospitalized due to high blood glucose on (b)(6) 2017, with blood glucose of 870 mg/dl.Customer stated that she began to feel thirsty as well as fatigued and realized that her blood glucose was high.Customer did not mention any form of treatment for the high blood glucose.The customer was treated with manual injection.The customer was wearing the insulin pump during the hospitalization.Customer also reported that the insulin pump had a keypad anomaly.The customer¿s blood glucose was 870 mg/dl at the time of incident.Customer stated that the insulin pump buttons works intermittently.No significant events leading to keypad anomaly were observed.Keypad anomaly troubleshooting was performed and confirmed that time is advancing.Customer the customer was advised to discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAB
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 6745611
• MDR Text Key: 81113052
• Report Number: 2032227-2017-31439
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507746
• UDI-Public: (01)00643169507746
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAB
• Device Catalogue Number: MMT-751LNAB
• Device Lot Number: A4751LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 132