MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problems No Display/Image (1183); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

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 insulin pump had a blank display.The customer¿s blood glucose level was unknown.Customer states the display was not blank less than 30 seconds.Customer states display was blank currently.Customer states the contacts on the battery cap was missing.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.Insulin pump will be returned for analysis.

Manufacturer Narrative

Device powered up properly after battery installation.No blank display noted.Device passed the self test, sleep current measurement, active current measurement, and the displacement test.Device was monitored and no unexpected powering off or blank display noted.Verified the battery tube power connector is properly connected to electrical board during visual inspection.Device was also received with the serial number label stained and faded.(b)(4).

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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: 8456077
• MDR Text Key: 140140288
• Report Number: 3004209178-2019-72453
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169873834
• UDI-Public: (01)00643169873834
• 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: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG2G6AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• 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: 48 YR
• Patient Weight: 61