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

Model Number MMT-332A

Device Problems Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)

Patient Problems Hyperglycemia (1905); Convulsion, Clonic (2222)

Event Date 06/29/2021

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

Event Description

Medtronic legal received information regarding defective insulin pump from the attorney of the family.The information received on (b)(6) 2021 stated insulin pump failed in its delivery of insulin to her, resulting in an acute episode hyperglycemia and seizures, which required emergency medical treatment from paramedics, the customer was using minimed 670 series insulin pump.The insulin pump revealed the retainer ring was broken.The insulin pump as well as reservoir will not 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 12140752
• MDR Text Key: 260675963
• Report Number: 2032227-2021-165889
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• 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: UNOMED-INF SET
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 216