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

Model Number	MMT-522NAS
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/16/2018
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.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 experience the high blood glucose.The customer¿s blood glucose level was in the range of 400 mg/dl.At the time of incident.Customer¿s current blood glucose level was 317 mg/dl.Customer¿s also experienced blood glucose around 500 mg/dl.Customer was treated with manual injection.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with broken reservoir tube lip, cracked battery tube threads.Cracked case at the display window corners and cracked lcd window.However, device received unable to perform all functional testing including the displacement, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test due to completely broken reservoir tube lip.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS
• 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: 8039833
• Report Number: 2032227-2018-56027
• Device Sequence Number: 1262736
• Product Code: OYC
• UDI-Device Identifier: 00613994622655
• UDI-Public: (01)00613994622655
• 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,Followup
• Report Date (Section B): 05/05/2020

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-522NAS
• Device Catalogue Number: MMT-522NAS
• Device Lot Number: A6522NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 10/21/2018
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 05/06/2020
• 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: FRN-MMT-RSVR UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 172