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

Model Number	MMT-332A
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	03/07/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer¿s husband reported via phone call that the customer experienced the low blood glucose of 40 mg/dl and doctor had taken her pump away from her.The customer was overdosed and they were in the nursing home.The customer¿s husband declined the low blood glucose troubleshoot.The devices will not be returned for the analysis.Updated summary: the customer was not using auto mode at the time of the incident per the customer's doctor's office.The customer had low symptoms such as being unresponsive.The customer's blood glucose was 70 mg/dl at the time of hospitalization.The customer was given glucagon to treat the low.The caller stated the customer had been getting forgetful recently.The pump was donated to the doctor's office.2nd updated summary: the customer's spouse called and stated that the customer was no longer on the pump.The caller stated the customer was using the pump in manual mode and it over delivered.The customer has been in a nursing home since the incident.

• Brand Name: RESERVOIR 3ML MMT-332A
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 11045383
• Report Number: 2032227-2020-219532
• Device Sequence Number: 16399773
• Product Code: FRN
• UDI-Device Identifier: 00643169786554
• UDI-Public: (01)00643169786554(17)220808(10)HG3N54R
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/08/2022
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG3N54R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OZP-MMT-7020-SNSR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 215