MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751RNAH; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751RNAH
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/31/2018
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 the patient¿s blood glucose was high.The customer reported that she's been waking up with high blood glucose and tried adjusting her basals and she's still waking up high.Patient's blood glucose at time of incident was unknown.Patient's current blood glucose was 183 mg/dl.The customer had some difficulty in breathing and extreme thirst.The customer was at 461mg/dl at 1pm and was 302mg/dl when she woke up.Based on customer report customer does not allege pump was under delivering.Customer states the drive support cap appears normal.Customer is not calling back to perform a high pressure test.Customer feels pump is under-delivering, and would like it replaced.Customer is treating for high blood glucose by bolusing with the pump and adjusting basals.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion, occlusion, prime or compromised force sensor system alarm and excessive no delivery test.Device received with minor scratched lcd window, cracked case at the display window corners, cracked lcd window, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, stained address or serial number label and cracked reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-751RNAH
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7284698
• Report Number: 3004209178-2018-52196
• Device Sequence Number: 1917823
• Product Code: OZO
• UDI-Device Identifier: 00643169507975
• UDI-Public: (01)00643169507975
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/04/2018

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-751RNAH
• Device Catalogue Number: MMT-751RNAH
• Device Lot Number: A3751RNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: 64 YR
• Patient Weight: 130