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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105ELPKNA ELI LILY PINK; SYRINGE, PISTON

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COMPANION MEDICAL INC INPEN MMT-105ELPKNA ELI LILY PINK; SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELPKNA
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2023
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.Serial number: n/a, lot number: b1059, software version: n/a, color: pink, battery life remaining: n/a, first bond date: n/a, initial battery %: n/a, last bond date: n/a, last battery %: n/a, user mobile device: samsung a53 android: 13, testing mobile device: iphone 12 and galaxy s21 5g android: 13 and ios: 16.6 customer reports: inpen not pairing to app.Per visual inspection: no physical damage to cartridge holder or inpen front and back shell was noted.Cartridge holder locks properly in place.The leadscrew was received 1/4 it's travel.Several attempts were made to pair inpen, every time app displayed ¿inpen not found¿.The inpen does not pair with commercial mobile app.Inpen did not transmit to manufacturing app.Performed battery investigation and battery measured 0.26v.Unable to perform baseline wireless functionality or displacement dose accuracy test.Inpen passed front cap investigation.In conclusion: inpen did not transmit doses to app due to depleted battery (0.26v).Therefore, the customer concern if inpen not pairing to app was confirmed.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.
 
Event Description
Information received by medtronic indicated that customer reported pairing issue between inpen and mobile device.Troubleshooting was performed it was reported that the issue was not resolved by bluetooth was enabled and turning off other mobile devices paired to current inpen dose knob/dial is not difficult to turn and the issue was not resolved.No harm requiring medical intervention was reported.It is unknown if the customer will continue to use the device was returned for analysis.
 
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Brand Name
INPEN MMT-105ELPKNA ELI LILY PINK
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
COMPANION MEDICAL INC
1223 world trade drive, 100
san diego CA 92128
Manufacturer (Section G)
COMPANION MEDICAL INC
1223 world trade drive, 100
san diego CA 92128
Manufacturer Contact
lusine boyadzhyan
1223 world trade drive, 100
san diego, CA 92128
MDR Report Key17753931
MDR Text Key323495647
Report Number3012822846-2023-01592
Device Sequence Number1
Product Code FMF
UDI-Device Identifier0000108620880003
UDI-Public(01)0000108620880003(17)240418(10)B1059
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/18/2024
Device Model NumberMMT-105ELPKNA
Device Catalogue NumberMMT-105ELPKNA
Device Lot NumberB1059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2023
Date Manufacturer Received08/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/18/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Age61 YR
Patient SexFemale
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