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 Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problems Hypoglycemia (1912); Irritation (1941); Pneumonia (2011); Hip Fracture (2349); Coma (2417)

Event Date 09/07/2018

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 hypoglycemia, comatose, pneumonia and then went to rehab, on (b)(6) 2018 with blood glucose level was 12 mg/dl at time of incident and current blood glucose 158 mg/dl.The customer was assisted with troubleshooting.Customer states they fell and broke hip and the bottom part of insulin pump looks like it was splitting on the bottom part and was having issues with the battery cap part.Customer states the drive support cap looks like it was slightly indented.The silhouette was irritating customer¿s skin, the cannula was irritating it.Customer states that the battery was did not always screw into the insulin pump.Customer has been using insulin pump system within 48 hours of reported low blood glucose event.Customer states during the last set change customer recalls insulin was dripping from end of set before connecting at their site.Customer reports programming was accurate.Customer states they had a low reservoir warning of 25 units.Customer reports insulin pump was worn during a medical procedure or test around magnetic resonance image.Customer did not allege insulin pump was over delivering.Customer advised to discontinue use of the insulin pump due to damages.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
• 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: 8415670
• MDR Text Key: 138634055
• Report Number: 3004209178-2019-66914
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• 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
• Date Manufacturer Received: 03/07/2019
• Date Device Manufactured: 02/04/2015
• 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, UNO INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 330