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

Model Number MMT-751LNAP

Device Problems Crack (1135); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Date 12/11/2017

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 was reported via phone call that, the customer had high blood glucose of 435 mg/dl.Customer received 3 different replacement pumps on her previous paradigm pumps due to cracks on the first and second one and third one time.Customer declined troubleshooting for the high blood glucose.One night woke up and heard ticking and looked a pump was giving her insulin and she did not program it to.The insulin pump will be returned for analysis.

Manufacturer Narrative

Insulin pump passed displacement test, rewind test, basic occlusion test, prime or compromised force sensor system alarm test, excessive no delivery test, occlusion test, self test and unexpected restart error test.No bolus anomaly noted during testing.Pump passed all operating currents tested within the specific range and passed off no power test.Pump passed the delivery accuracy test.Pump received with cracked reservoir tube lip, missing drive support sticker and minor scratches on display window noted.

• Brand Name: 530G INSULIN PUMP MMT-751LNAP
• 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: 7187315
• MDR Text Key: 97137608
• Report Number: 3004209178-2018-43097
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169933217
• UDI-Public: (01)00643169933217
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAP
• Device Catalogue Number: MMT-751LNAP
• Device Lot Number: A5751LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 210