MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAP
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/16/2019
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 reported via phone call that the customer experienced hyperglycemia.The customer's blood glucose value was 454 mg/dl at the time of incident and other blood glucose was 340 mg/dl.Customer reported that they received stuck button.Customer stated that nothing comes up on the insulin pump even if she presses any button.Customer stated that about 5.00 am threw up since her blood glucose was at 340 mg/dl and stated that insulin pump did not gave her bolus then got up to 454 mg/dl.Customer stated that she was stuck on main screen.Customer tried to press all the button on the device but no response also stated that clip broke and insulin pump fell off from waist and got crack and damaged at reservoir.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with cracked reservoir tube lip and broken belt clip slot, however, device had unresponsive buttons at esc and act due to unlocked j2 or lcd keypad connector during visual inspection.Unable to perform operating currents, self test, a21 error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify under delivery due to unresponsive button.
Additional Manufacturer Narrative
Device received with cracked reservoir tube lip and broken belt clip slot, however, device had unresponsive buttons at esc and act due to unlocked lcd keypad connector during visual inspection.Unable to perform operating currents, self test, a21 error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify under delivery due to unresponsive button.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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: 9347239
• Report Number: 2032227-2019-120335
• Device Sequence Number: 16201828
• Product Code: OYC
• UDI-Device Identifier: 00613994748744
• UDI-Public: (01)00613994748744
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 05/21/2020

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-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000168682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/16/2019
• Supplement Date Received by Manufacturer: 02/03/2020; 05/20/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 02/06/2020; 05/21/2020
• 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-MMT-332-RSVR,OZO-MMT-7008-SNSR,UNOMEDSET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR