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

Model Number MMT-751NAS

Device Problems Mechanical Problem (1384); Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 07/19/2020

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.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¿s mother reported via phone call that they were experiencing high blood glucose.Blood glucose level at the time of the incident was 571 mg/dl and current was 312 mg/dl.Customer stated that she received motor error and the insulin pump kept asking for rewind as she got motor error 3 times during the bolus delivery.Customer stated that she took 7 units of a manual injection.Customer stated that was feeling sleepy and had dry mouth.Customer stated that stated the serial number sticker came off her insulin pump.Customer was able to clear alarm and insulin pump rewind.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10324971
• MDR Text Key: 200383595
• Report Number: 2032227-2020-152662
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• 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: 07/27/2020

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-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 07/27/2020
• Date Device Manufactured: 10/06/2014
• 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-MMT UNK-RSVR, UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 160