MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KR

Device Problem No Display/Image (1183)

Patient Problem Bruise/Contusion (1754)

Event Date 06/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

Customer reported via phone call that the insulin pump had a blank display.The customer¿s blood glucose level was 110 mg/dl at the time of the incident.The customer was assisted with troubleshooting and customer reports display was blank currently.Customer states the display was not blank less than 30 seconds and did not return.The customer removes the battery and stated the insert battery alarm did not display on the insulin pump screen.Customer states the contact on the battery cap was neither missing nor damage.Customer states battery compartment was neither damaged nor corroded.Customer states the spring was neither damaged nor corroded.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed sleep current measurement, active current measurement, self test and displacement test.No unexpected low battery alarm, battery power loss alarm or blank display noted during testing.(b)(4).

• Brand Name: 630G INSULIN PUMP MMT-1715KR 630G
• 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 ; 8185464805
• MDR Report Key: 8686358
• MDR Text Key: 147646279
• Report Number: 2032227-2019-14502
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000173036
• UDI-Public: (01)00763000173036
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KR
• Device Catalogue Number: MMT-1715KR
• Device Lot Number: HG35TY2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2019
• 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 Age: 63 YR
• Patient Weight: 93