MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722LNAP
Medical Device Problem Codes	Failure to Cycle (1142); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/14/2020
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 the customer was experienced high blood glucose level.Customer¿s blood glucose level was over 400 mg/dl and 473 mg/dl.Customer was treated with manual injection of 20 units.Customer also reported that the insulin pump alarmed compromised force sensor system.The customer stated that the drive support cap was protruded.Troubleshooting was performed for insulin pump error alarm.The customer was advised that the insulin pump needed to be replaced, 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 protruded drive support disk.Unable to perform prime or a33 test, excessive no delivery test and occlusion test or verify a33 alarm due to motor error alarm.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAP
• 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: 9609329
• Report Number: 2032227-2020-100604
• Device Sequence Number: 11423552
• Product Code: OYC
• UDI-Device Identifier: 00613994409546
• UDI-Public: (01)00613994409546
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/19/2020

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-722LNAP
• Device Catalogue Number: MMT-722LNAP
• Device Lot Number: A000114634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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,UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 109