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

Model Number	MMT-551LNAH
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that they were experiencing high and low blood glucose.Blood glucose level at the time of the incident was 400 mg/dl and then could not correct until she was over 350 mg/dl.Customer other blood glucose values were 42 mg/dl and could not be awakened not get it to go up and she could not get it over 100 mg/dl and now this morning was 348 mg/dl and then 143 mg/dl.Customer stated that there was crack at two places battery compartment and reservoir compartment.Customer declined to troubleshoot for high blood glucose as she said she feels it was due to damage and just needs it replaced.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551LNAH
• 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; * 00777-3869
• MDR Report Key: 10349863
• Report Number: 2032227-2020-155987
• Device Sequence Number: 19441184
• Product Code: OZO
• UDI-Device Identifier: 00643169507708
• UDI-Public: (01)00643169507708
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 07/31/2020

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-551LNAH
• Device Catalogue Number: MMT-551LNAH
• Device Lot Number: A4551LNAHJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/31/2020
• 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-MMT 332A-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Weight: 68