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U.S. Department of Health and Human Services

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

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COMPANION MEDICAL INC INPEN MMT-105ELGYNA ELI LILY GRAY; SYRINGE, PISTON Back to Search Results
Model Number MMT-105ELGYNA
Device Problems Computer Software Problem (1112); Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
Event Type  malfunction  
Manufacturer Narrative
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.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.
 
Event Description
It was reported to medtronic minimed that the customer experienced difficult to dial/dose, dose log/report data inaccuracy.The customer reported no adverse event.The event involved product(s) mmt-105elgyna.Troubleshooting was performed for the event.No harm requiring medical intervention was reported.Mmt-105elgyna was requested and customer response was the device will be returned.
 
Manufacturer Narrative
Inpen did not pair with commercial app.However, inpen did transmit to manufacturing app.Received inpen [ 1/4 ] of travel.Performed encoder bond investigation and found that the encoder pattern wheel tabs rotating and traveling off the keyed slots of dose nut guides.Encoder pattern wheel should never rotate.This causes an unexpected travel of the encoder pattern wheel creating resistance to dial and dispensing.Also, plastic shavings contamination builds up found caused by encoder wheel tabs rubbing at the walls of the dose nut.Abrasions only at the top section of the dose nut.Unable to perform baseline/wireless functionality and displacement dose accuracy test.Inpen failed front cap investigation.Inpen front shell does not fit securely onto cartridge holder due to small snap arm being cracked / broken.In conclusion: it was determined from destructive analysis that the difficult to dial/dose was caused by a pattern wheel misalignment due to an encoder base bond failure.This can affect insulin delivery.Therefore, the customer concern of dose dial being difficult to dial/dose was 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
INPEN MMT-105ELGYNA ELI LILY GRAY
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 Key19103354
MDR Text Key340343830
Report Number3012822846-2024-00421
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000320
UDI-Public(01)000010862088000320(17)231025
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 04/14/2024
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 Expiration Date10/25/2023
Device Model NumberMMT-105ELGYNA
Device Catalogue NumberMMT-105ELGYNA
Device Lot NumberB0792
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/25/2024
Initial Date FDA Received04/15/2024
Date Device Manufactured10/25/2021
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 Age59 YR
Patient Weight75 KG
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