MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522LNAH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional 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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that they experienced low blood glucose and need to go emergency medical service.The customer was treated with intravenous.The customer stated that reservoir ring was missing and was able to lock in place.The customer did not report any symptoms related to low blood glucose level.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The information that provided with the initial report was incorrect.The correct information has been included with this report.(b)(4).
Event or Problem Description
It was reported that the retainer ring was cracked/missing.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.08720 inches.The stop current and run current measurement tests are within specification.Unit also passed self test, off no power alarm test and a21 error test.Device uploaded properly using carelink.Device had missing reservoir tube o-ring, a partially broken off cracked reservoir tube lip, cracked battery tube threads and a missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAH
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 9894793
• Report Number: 3004209178-2020-91449
• Device Sequence Number: 13976828
• Product Code: OYC
• UDI-Device Identifier: 00613994597212
• UDI-Public: (01)00613994597212
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 06/21/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-522LNAH
• Device Catalogue Number: MMT-522LNAH
• Device Lot Number: A1522LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/15/2020; 06/19/2020
• Initial Report FDA Received Date: 03/28/2020
• Supplement Report FDA Received Date: 05/19/2020; 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 159