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

Model Number	MMT-522LNAS
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/06/2020
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.(b)(4).
Event or Problem Description
Customer called and reported that they received emergency medical assistance due to low blood glucose with unknown blood glucose levels at the time of the incident.The customer did not mention how they were treated.The customer did not mention any symptoms.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed and as the customer declined as they stated the low was not caused by a pump issue.The customer reported pump physical damage and a reservoir that could not lock into the pump.The insulin pump will not be returned for analysis on this case.
Additional Manufacturer Narrative
Device passed the rewind test, prime/a33 test and excessive no delivery test.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Unable to perform the displacement test, basic occlusion test, occlusion test and delivery accuracy test due to completely broken off reservoir tube lip.Unable to verify the no delivery alarm during the basic occlusion test and on the occlusion test due to completely broken off reservoir tube lip.The test p-cap and reservoir will not lock in place in the reservoir compartment due to completely broken off reservoir tube lip.Device also had a missing reservoir tube o-ring, cracked display window, cracked case at display window corner, cracked battery tube threads, cracked case at the reservoir tube window corner, cracked reservoir tube window and a missing end cap sticker.Device uploaded properly using care link.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAS
• 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: 9600175
• Report Number: 2032227-2020-100584
• Device Sequence Number: 2573374
• Product Code: OYC
• UDI-Device Identifier: 00613994407696
• UDI-Public: (01)00613994407696
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/10/2020

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-522LNAS
• Device Catalogue Number: MMT-522LNAS
• Device Lot Number: A000114248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 04/10/2020
• 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-UNK-RSVR UNOMED SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 53 YR
• Patient Weight: 120