MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522LNAL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
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 the insulin pump had motor error alarm.The customer¿s blood glucose level was 215 mg/dl at the time of the incident.The customer stated that the drive support cap was normal.The customer was assisted with troubleshooting.Customer was reported that they were able to clear and rewind the insulin pump.Customer stated that the insulin pump was exposed to x-rays.Customer was also reported that they were unable to go to the status screen and stuck in rewind option.The customer was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test.Device received with motor error alarm during the basic occlusion test due to loose or flush drive support disk.Unable to perform prime or a33 test, excessive no delivery test and occlusion test due to motor error alarm.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 9217346
• Report Number: 2032227-2019-107479
• Device Sequence Number: 2734287
• Product Code: OYC
• UDI-Device Identifier: 00613994407719
• UDI-Public: (01)00613994407719
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 03/06/2020

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 Model Number: MMT-522LNAL
• Device Catalogue Number: MMT-522LNAL
• Device Lot Number: A000113848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 130