MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAB
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/28/2019
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.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's family member reported via phone call that they experienced high blood glucose.The customer¿s blood glucose level was 257 mg/dl,448 mg/dl.The customer was treated with bolus.Customer also reported buttons were unresponsive troubleshooting was performed and keypad ramping uncontrollably.The customer declined troubleshoot for high blood glucose.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device had unresponsive buttons at esc and act due to unlocked j2/lcd keypad connector during visual inspection.Unable to perform operating currents, self test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test or verify ramping due to unresponsive button.No button error alarm during testing.However, corrosion was found at the keypad traces.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB
• 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: 8485960
• Report Number: 2032227-2019-02878
• Device Sequence Number: 1928144
• Product Code: OYC
• UDI-Device Identifier: 00643169221512
• UDI-Public: (01)00643169221512
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/23/2019

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-523RNAB
• Device Catalogue Number: MMT-523RNAB
• Device Lot Number: A000207242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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 INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Weight: 168