MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1712KL 640G V4.10 BK SF MG; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-1712KL |
Device Problems
Device Alarm System (1012); No Display/Image (1183); Visual Prompts will not Clear (2281); Key or Button Unresponsive/not Working (4063)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed outside the united states.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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Event Description
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Information received by medtronic indicated that the customer reported blank display, frozen display and buttons were not responding in pump.The customer reported no alarms occurred during or after the time that the buttons were not responding.Troubleshooting was performed.No harm requiring medical intervention was reported.The customer will discontinue the use of the device and revert to the backup plan as per health care professional instructions.The pump will be returned for analysis.
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Manufacturer Narrative
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The pump was received with a critical pump error (open book image) alarm after battery installation.No blank or frozen display noted.Unable to perform the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test, and dat test or verify unresponsive keypad due to the critical pump error (open book image) alarm.Successfully utilized crest and thus to download history files, traces, and comlink3 files.A review of the pump history file reveals on (b)(6) 2024 at 08:13:44 a pump error 35 alarm was triggered which caused the critical pump error (open book image) alarm.The pump was cut open to perform a visual inspection.Moisture damage was found on the electronic assembly (pcba 1 and pcba 2), vibrate harness assembly, motor, force sensor, and inside the battery tube.A test p-cap does lock into place inside the reservoir compartment properly.The following were noted during the physical inspection: scratched case, stained keypad overlay, cracked battery tube threads, cracked battery compartment at the corner of the belt clip rails, stained and peeling serial number label, and pillowing keypad overlay.Blank and frozen displays are not confirmed.Critical pump error (open book image) and pump error 35 alarms are confirmed due to moisture damage on the force sensor.Unresponsive keypad is unknown due to the critical pump error (open book image) alarm.Audio/vibrate anomaly/absence of alarm is not confirmed.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.
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