The pump passed the displacement test, rewind test, prime/seating test, occlusion test, force sensor test, sleep current test, active current test, and self-test.Pump was cut open to perform visual inspection and found no physical or moisture damage to the keypad assembly, electronic assembly, or motor.The j1 connector on pcba 1 was locked properly during visual inspection.Successfully downloaded history files and traces using thus.No stuck key alarm found in the history files or traces.No backlight anomaly was found.Pump passed the keypad voltage test.Test p-cap and reservoir locked properly into reservoir compartment during testing.The following were noted during visual inspection: pillowing keypad overlay, scratched case, cracked case (battery tube), cracked case on corner of belt clip rails and minor scratches on lcd window.In summary, customers alleged unresponsive keypad, backlight anomaly and prime/fill anomaly was not confirmed during testing.No motor related alarms were noted in the history files.Pump passed full dry test.Pump passed keypad voltage test.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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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.The information that provided with the initial report was incomplete.The complete information has been included with this report in b5 section.The information related to health effect- clinical code and component code has been updated and provided in h6 section of this report.
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