MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723LNAP
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); No Apparent Adverse Event (3189); Priming Problem (4040)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/01/2020
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
Customer reported via phone call that they experienced low blood glucose level.Customer's blood glucose value was 50 mg/dl and other blood glucose was 46 mg/dl.The customer was treated with food.The customer stated buttons were not responding.Customer has been using insulin pump system within 48 hours of reported low blood glucose event.Customer stated that the drive support cap was normal.The customer reported that they did not believe insulin pump was over-delivering.The customer recalls insulin dripping from end of set before connecting at their site.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with no button response at express bolus, esc, act, up and down due to unlocked j2/lcd keypad connector during visual inspection.Unable to perform operating currents, self test, displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test and excessive no delivery test due to no button response.No button error alarm during testing.However, keypad flattened button dome switch was found on act.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAP
• 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: 10342647
• Report Number: 2032227-2020-154873
• Device Sequence Number: 2963790
• Product Code: OYC
• UDI-Device Identifier: 00643169513907
• UDI-Public: (01)00643169513907
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/02/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723LNAP
• Device Catalogue Number: MMT-723LNAP
• Device Lot Number: A5723LNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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: Other
• Patient Age: 34 YR
• Patient Weight: 51