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 Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Sweating (2444)

Event Date 05/13/2019

Event Type  Injury  

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 customer was hospitalized due to hyperglycemia on (b)(6) 2019.The customer¿s blood glucose level was 29 mg/dl at the time of incident.The customer was assisted with troubleshooting.The customer was treated with manual injection and insulin drip during hospitalization.Customer was using insulin pump system within 48 hours of reported high blood glucose event.The customer stated that the symptoms related to high blood glucose such as sweating.Customer reports they contacted their health care professional regarding the high blood glucose.Customer was not alleging insulin pump was under delivering.Customer stated insulin pump displayed critical pump error on the insulin pump.Customer was unable to complete carelink upload.The insulin pump will be returned for analysis.

Manufacturer Narrative

The device was received with a critical pump error (open book image) alarm due to due to strong magnetic field alarm was generated.Also, strong magnetic field caused pump malfunctioning: alarm ( hal sensor) was generated on main and alarm 18 (virtual watchdog) was generated on motor causing motor inability to communicate with main ¿ main generated alarm 3 and after restart another alarms 3 that caused open-book in result.

• 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: 8618709
• MDR Text Key: 145345149
• Report Number: 3004209178-2019-98601
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169873834
• UDI-Public: (01)00643169873834
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG2P82B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2018
• 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
• Treatment: FRN-UNK-RSVR, UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 170