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

Model Number	MMT-523RNAH
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/20/2017
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
Customer called and reported that they got hospitalized due to low blood glucose on (b)(6) 2017 with blood glucose so low that a meter couldn't read it at the time of the incident.The customer was at 230 mg/dl at the time of the call.The customer used food to treat.The customer experienced symptoms such as loss of consciousness.The customer was wearing the insulin pump during the incident.Troubleshooting was completed and the customer believes the pump over delivered insulin.The customer also stated that they felt the pump over delivering so they ate bread and a teaspoon of honey to treat.The customer also stated they were having highs.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Findings: unit received with operating currents within spec.Unit passed selftest, unexpected alarm error test, rewind, basic occlusion test and displacement test.However, unable to prime unit during prime test due to faulty force sensor resistor.Unable to perform excessive no delivery test, occlusion test, displacement accuracy test or verify over delivery anomaly due to prime anomaly.The motor was tested outside the device and passed.Unit received with cracked case at display window corners, cracked reservoir tube window, cracked reservoir tube, cracked battery tube threads and minor scratches on lcd window.Unit received with corroded battery tube.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH
• 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: 6842991
• Report Number: 2032227-2017-44568
• Device Sequence Number: 16258534
• Product Code: OYC
• UDI-Device Identifier: 00613994918642
• UDI-Public: (01)00613994918642
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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-523RNAH
• Device Catalogue Number: MMT-523RNAH
• Device Lot Number: A000205315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 81 YR
• Patient Weight: 165