MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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Model Number MMT-1715K |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Insulin pump passed sleep current measurement, active current measurement, self test and displacement test.No unexpected low battery alarm noted during testing.Pump trace download analysis confirmed the pump alarmed power loss alarm, replace battery alert, replace battery now alarm.The power management tool indicated abnormal behavior of the lithium backup battery loaded voltage (loaded vlith) as shown on the power management graph and confirmed power loss alarm, replace battery alert and replace battery now alarm due to connector resistance j6 /pcb 1.After disconnecting and reconnecting the internal battery connector on j6/pcb 1, the pump was monitored and functioned properly.Unit was received with partially detached reservoir retainer, scratched case, minor scratched lcd window and faded serial number label.
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Event Description
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The customer reported via phone call that insulin pump had battery issue.The blood glucose at the time of the incident was unknown.The device will be returned for analysis.
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Manufacturer Narrative
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This report is part of a retrospective review and remediation efforts in response to a warning letter.Updated h9: z-0955-2020.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.
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