MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751LNAS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Nausea (1970); Vomiting (2144)

Event Date 06/10/2019

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

The customer reported via phone call that she was hospitalized on (b)(6) 2019 as she fell down unconsciousness, had hypertension, and high blood glucose of 600 mg/dl.The customer experienced symptoms such as nausea, vomiting, abdominal pain, and difficulty in breathing.The customer was treated with insulin drip.The other blood glucose values of the customer were 202 mg/dl and 219 mg/dl.The customer was assisted in troubleshooting.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and delivery accuracy test at 0.08750 inches.The stop (idle) current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device uploaded properly using carelink.Device had scratched reservoir tube window.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• 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: 8706620
• MDR Text Key: 148259070
• Report Number: 2032227-2019-17484
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169933224
• UDI-Public: (01)00643169933224
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A5751LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2018
• 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 SET
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 110