MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number MMT-332A

Device Problem Low Battery (2584)

Patient Problem Hypoglycemia (1912)

Event Date 04/07/2018

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer called and reported that they received emergency medical assistance due to low blood glucose on (b)(6) 2018 with blood glucose of 60 mg/dl at the time of the incident.The customer was wearing the insulin pump during the incident.The customer states the pump is delivering deprogrammed boluses, and their blood glucose levels drop from 160 to 55 mg/dl.Troubleshooting was completed but did not resolve the issue.The customer also reported a low battery alarm.The customer also had paramedic visits for lows on (b)(6) 2018.The insulin pump will be returned for analysis.

• Brand Name: RESERVOIR 3ML MMT-332A
• Type of Device: PUMP, INFUSION
• 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: 7499187
• MDR Text Key: 107769774
• Report Number: 3004209178-2018-70448
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 20613994625476
• UDI-Public: (01)20613994625476(017)20190107
• 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
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2019
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG0THE0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 530G INSULIN PUMP MMT-751LNAL; INFST MMT-386 QCKSTPRDGM 10PK 9MM32N
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 290