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

Model Number	MMT-332A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluated 1 open/used reservoir (transfer guard not returned).Using a new lab transfer guard; performed pre-fill reservoir test, found leakage anomaly during filling.Also performed a visual inspection, performed a visual inspection and found a large crack at top of the reservoir.
Event or Problem Description
The customer reported via phone call that the insulin squirted out and reservoir had leak at past the o rings.The customer¿s blood glucose level was 168 mg/dl at the time of incident.The customer also stated that the self test was passed.Customer stated that leak occurred during priming.The customer stated that the insulin pump was exposed to moisture.The reservoir will be returned for analysis.

• 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
• MDR Report Key: 8958435
• Report Number: 2032227-2019-56353
• Device Sequence Number: 2609341
• Product Code: FRN
• UDI-Device Identifier: 00643169786547
• UDI-Public: (01)00643169786547(17)210605(10)HG2L57H
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/05/2021
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG2L57H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 245