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

Model Number MMT-332A

Device Problems Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)

Patient Problems Hypoglycemia (1912); Blood Loss (2597)

Event Date 05/18/2020

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

The customer reported via phone call that they experienced low blood glucose.Blood glucose reading was 50 mg/dl.Customer¿s other blood glucose values are 156 mg/dl and 96 mg/dl.The customer stated that there was blood at site.Customer was treated with orange juice for their low.The customer alleged that insulin pump was over delivering insulin.Customer had been using insulin pump system within 48 hours of reported low blood glucose event.Customer did not use auto mode feature at the time of incident.Customer was neither in emergency room nor admitted into hospital.The pump 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: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10085751
• MDR Text Key: 191971655
• Report Number: 2032227-2020-121762
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00643169786554
• UDI-Public: (01)00643169786554(17)220419(10)HG3C5H7
• 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: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2022
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG3C5H7
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Date Device Manufactured: 04/19/2019
• 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: FRN-MMT-332-RSVR, UNO INF SET, OZP-MMT-7020-SNSR
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 132