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

Model Number MMT-751LNAH

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Pregnancy (3193)

Event Date 12/09/2019

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they were hospitalized due to high blood glucose level on (b)(6) 2019 with blood glucose level of 200 mg/dl.Customer stated that the reading was different between the sensor and the meter.Customer was treated with insulin drip and low carbohydrate diet.Customer had high blood glucose level while pregnant.Customer stated that they did not need to troubleshoot for high blood glucose.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAH
• 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: 9494189
• MDR Text Key: 173278426
• Report Number: 2032227-2019-135338
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507753
• UDI-Public: (01)00643169507753
• 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
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAH
• Device Catalogue Number: MMT-751LNAH
• Device Lot Number: A4751LNAHJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2019
• Date Device Manufactured: 09/13/2016
• 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
• Patient Age: 37 YR
• Patient Weight: 180