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

Model Number	MMT-523RNAS
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/06/2018
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 they experienced low blood glucose.The customer¿s blood glucose level was in the range of high 50 mg/dl, 60 mg/dl and in the range of 60 mg/dl to 70 mg/dl.The current blood glucose level is 111 mg/dl.The customer treated for low blood glucose value with food.Based on customer¿s report customer allege the insulin pump was over delivering reason that they received a reminder of a missed bolus after delivering a bolus and then went low.The customer stated that the drive support cap was normal.The customer was neither in the emergency room, nor admitted into hospital as a result of low blood glucose.The customer was wearing the insulin pump when low blood glucose event was reported.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery test.No device deficiency anomaly noted during test.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS
• 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: 8145895
• Report Number: 2032227-2018-72879
• Device Sequence Number: 11189040
• Product Code: OYC
• UDI-Device Identifier: 00613994748706
• UDI-Public: (01)00613994748706
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/16/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-523RNAS
• Device Catalogue Number: MMT-523RNAS
• Device Lot Number: A000167945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 05/16/2019
• 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 SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 51