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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hyperglycemia (1905); Pain (1994)

Event Date 05/10/2017

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

It was reported that the meter was off by 30 points and the customer was hospitalized on (b)(6) 2017 for high blood glucose ranging from 300 mg/dl to 400 mg/dl.The customer had a throbbing headache and a high keytone count.The customer was discharged from the hospital on (b)(6) 2017 and was questioning the reading taken on (b)(6) 2017.The medical doctor ran tests on the customer to see if it was her heart that was causing the high blood glucose.The medical doctor prescribed a cheap meter and compared it with next link.The customer sometimes uses lancets twice before replacing them.Nothing further was reported.

• 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
• MDR Report Key: 6660490
• MDR Text Key: 78176730
• Report Number: 2032227-2017-22780
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507784
• UDI-Public: (01)00643169507784
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• 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: A4751LNASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 139