MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712K; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712K

Device Problems Intermittent Continuity (1121); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

It was reported that, the insulin pump turns off and rewinds on its own and had multiple insulin pump errors.The blood glucose was 120 mg/dl at the time of the incident.Customer stated that, they are not able to rewind the pump.Assisted with performing displacement test and which was passed.Assisted with rewinding the pump ans error did not occur during rewind.Assisted the customer with load reservoir and fill tubing process and error did not occur.The error table indicates the pump should be replaced.Based on alarm history, pump needs to be replaced due to multiple pump errors.The customer advised to discontinue use of the pump and revert to a back-up plan.The device will not be returned for analysis.

Manufacturer Narrative

Insulin pump passed the functional testings including the self-test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test.No unexpected pump error 53/68 noted during testing.However, pump error 53 alarm found in the insulin pump history (linenumber = 96 and filenumber = 99).Unable to determine root cause, problem isolated to electronic assembly.

• Brand Name: 640G INSULIN PUMP MMT-1712K
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• 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: 7283795
• MDR Text Key: 100662892
• Report Number: 3004209178-2018-52068
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169577688
• UDI-Public: (01)00643169577688
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712K
• Device Catalogue Number: MMT-1712K
• Device Lot Number: HG0PG10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2018
• 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 Age: 39 YR