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 Problem Circuit Failure (1089)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Weakness (2145); Dizziness (2194)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No hardware low level failure alarm noted during testing.Hardware low level failure alarm was present in the pump trace download due to broken trace on keypad assembly.Toggled on, off and increased, decreased volume with the audio feature functioning properly.No audio, vibrate, absence of alarm anomalies noted during testing.Insulin pump passed the self test, sleep current measurement, active current measurement, rewind test, prime, seating test, basic occlusion test and force sensor test.Unable to perform the displacement test, occlusion test and delivery accuracy test due to missing retainer.The test p-cap and reservoir will not lock in place in the reservoir compartment due to missing retainer.Insulin pump also had a missing reservoir tube o ring, scratched case, and cracked case at corner of the belt clip rail and pillowing keypad overlay.Insulin pump uploaded properly using carelink.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

Information received by medtronic indicated that they were hospitalized due to high blood glucose on june 04, 2020 and insulin pump had hardware low level failures alarm.Customer¿s blood glucose was 495 mg/dl.Customer was experienced symptoms like vomiting, dizziness, weakness and nausea.Customer was shortly taken to emergency and then to intensive care unit.Customer was performed self, displacement verification and high pressure test and it was passed.The insulin pump will be returned for analysis.

Manufacturer Narrative

The information provided with the initial report was incorrect.We have corrected the incident date in the narrative text to reflect that the customer was hospitalized on (b)(6) 2020 which has been updated on this report.

Event Description

Customer was hospitalized on (b)(6) 2020 due to high blood glucose.

• 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 ; 8185464805
• MDR Report Key: 10233176
• MDR Text Key: 197684593
• Report Number: 2032227-2020-141959
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169999770
• UDI-Public: (01)00643169999770
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• 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: HG22LCX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2017
• 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