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

Model Number MMT-551NAL

Device Problems Premature Discharge of Battery (1057); No Display/Image (1183); Loss of Data (2903); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

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.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 Description

Information received by medtronic indicated that the insulin pump had lots of alarm and also the unexpected restart and a cold reset was performed pump error alarm.Customer was able to clear the alarm and able to rewind the insulin pump.Insulin pump error alarm recurring while use.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

Manufacturer Narrative

On (b)(6), 2021, the customer returned pump for an alleged failed battery alarms, a21, a17 and pump turned off.Pump monitored for several days.Pump received with normal operating current.The stop (idle) current and run current measurement tests are within specification.Pump passed displacement test and a21 alarm test.No battery power loss alarm during testing.Pump history download using thds was successful.However, a47 alarms found on the history file which caused corrupted data.Unable to confirm the reported event date due to the corrupted data.A47 alarms are due to the pump not having power for a long period of time.The following were noted during visual inspection: cracked belt clip slot, cracked battery tube threads, missing end cap sticker, and cracked reservoir tube lip.The test p-cap/reservoir does lock into place.No moisture damage found on the electronics, motor, battery tube and vibrator assembly noted.No damage on the c13/lcd isolation tape noted.After inserting battery unit power properly.Pump monitored for several days and no blank display noted.No unexpected a21/17 anomalies noted.No unexpected battery power loss anomalies noted.No unexpected failed battery alarm not 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, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: 530G INSULIN PUMP MMT-551NAL
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 11722618
• MDR Text Key: 249507639
• Report Number: 2032227-2021-138824
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000643169503649
• UDI-Public: (01)000000643169503649
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAL
• Device Catalogue Number: MMT-551NAL
• Device Lot Number: A4551NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 105 KG