MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551PNAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551PNAB
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/12/2018
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
Customer called and reported that they experienced low blood glucose, with blood glucose of 40 mg/dl at the time of the incident.The customer was at 68 mg/dl at the time of the call.The customer used carbs to treat.The customer was wearing the insulin pump during the incident.Based on customer report proceeding in troubleshooting per customer alleging possible pump over delivery.The drive support cap appears normal.The customer believes the pump is over delivering.Troubleshooting was completed but did not resolve the issue.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The device was received with all operating currents within specification and passed functional testing including the rewind test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.No possible over delivery anomaly noted.The insulin pump was received with minor scratched lcd window, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, stained address, serial number label and cracked reservoir tube lip.

• Brand Name: 530G INSULIN PUMP MMT-551PNAB
• 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: 7424295
• Report Number: 3004209178-2018-64170
• Device Sequence Number: 1544212
• Product Code: OZO
• UDI-Device Identifier: 00643169507265
• UDI-Public: (01)00643169507265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/26/2018

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-551PNAB
• Device Catalogue Number: MMT-551PNAB
• Device Lot Number: A3551PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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: 57 YR
• Patient Weight: 170