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

Model Number MMT-751LNAL

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem Hyperglycemia (1905)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.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 their insulin pump was damaged.The customer¿s blood glucose level was 165 mg/dl.The customer reported that the top of reservoir cap was broken and it cracked and missing.Troubleshooting was performed for damage and observed that reservoir is unable to lock in place and it was loose.The customer declined the high blood glucose troubleshooting.Advised the pump will need to be replaced.Advised to discontinue use of the pump and revert to a backup plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device received with broken reservoir tube lip.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-751LNAL
• 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: 7652992
• MDR Text Key: 112952201
• Report Number: 3004209178-2018-86688
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507760
• UDI-Public: (01)00643169507760
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAL
• Device Catalogue Number: MMT-751LNAL
• Device Lot Number: A4751LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• 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 Age: 35 YR
• Patient Weight: 165