MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAP; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number	MMT-551NAP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to medtronic minimed that the customer experienced hypoglycemia.The customer also reported an unspecified issue.Blood glucose value at the time of the event was 45 mg/dl.The event involved product(s) mmt-551nap.Troubleshooting was performed.It is unknown whether the customer was using the auto mode/smart guard feature at the time of the event.It is unknown whether the customer was using the insulin pump system within 48 hours of the reported event.No further patient complications were reported.The customer will discontinue use of the insulin pump.Mmt-551nap was requested, and the device was returned for analysis.
Additional Manufacturer Narrative
Pump passed the displacement test.However, unit unable to communicate to test minilink and the glucose sensor simulator to verify lost sensor alarm, and carlink problem isolated to the y1 to the rf board.The following were noted during visual inspection: cracked case at the display window corners, cracked lcd window, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, stained address/serial number label, missing reservoir tube o ring and broken reservoir tube lip.The test infusion set and reservoir does not lock into place due to the reservoir tube lip completely broken off.In conclusion, lost sensor was confirmed due to rf board failure.Problem isolated to rf board.No communicate minilink was confirmed.This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: 530G INSULIN PUMP MMT-551NAP
• Common Device Name: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: keya patel ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 25026537
• Report Number: 2032227-2026-167943
• Device Sequence Number: 9039737
• Product Code: OZO
• UDI-Device Identifier: 00643169503656
• UDI-Public: (01)00643169503656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-551NAP
• Device Catalogue Number: MMT-551NAP
• Device Lot Number: A4551NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED SET, MDS-UNK-SNSR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 95 KG