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

Model Number	MMT-723RNAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/31/2017
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
The customer reported via phone call that after a knee surgery they experienced a high blood glucose level of 444 mg/dl and that the insulin pump also alarmed motor error twice.Troubleshooting for high blood glucose was performed.The customer treated with injections and was also hospitalized.Customer's blood glucose value was 527 mg/dl at the time of the call.The customer was hospitalized on (b)(6) 2017 at 12:00 p.M.With the blood glucose of 444 mg/dl.The customer was wearing the insulin pump during hospitalization.The drive support cap appeared normal.The customer declined further high blood glucose troubleshooting, so motor error troubleshooting was performed.The customer stated that the drive support cap appeared normal.The customer stated that the insulin pump was exposed to magnetic resonance imaging due to being told that it was okay to wear it during the procedure.The customer was able to complete pump rewind.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The customer also mentioned receiving battery out limit alarm and troubleshooting found that it was normal behavior due to the battery being out of the insulin pump greater than allowed.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The insulin pump was received with motor error alarm during basic occlusion test and unable to prime at 4.0 lbs during prime test due to faulty force sensor resistor.Unable to perform occlusion test due to motor error alarm.Motor passed motor test.Unit passed displacement test, rewind and excessive no delivery test.Drive support disk was inspected and no anomaly was noted.Unit was received with normal operating currents and no unexpected off no power alarm, low battery alarm or battery out limit alarm noted.Pump was received with missing end cap sticker, minor scratched lcd window, cracked battery tube threads, cracked belt clip slot at battery tube threads area and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAH
• 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: 6869150
• Report Number: 2032227-2017-48542
• Device Sequence Number: 661701
• Product Code: OYC
• UDI-Device Identifier: 00613994904416
• UDI-Public: (01)00613994904416
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 09/27/2017

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-723RNAH
• Device Catalogue Number: MMT-723RNAH
• Device Lot Number: A000248627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 09/02/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: Other
• Patient Age: 47 YR
• Patient Weight: 245