Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problems
Hypoglycemia (1912); Vomiting (2144)
|
Event Date 01/02/2024 |
Event Type
Injury
|
Event Description
|
A "replace sensor" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer felt nauseous and experienced vomiting.The customer was unable to self-treat, requiring a healthcare professional administration of intravenous glucose(dose unknown) for treatment.An hcp reading around 7 mmol was obtained and no further treatment was reported.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
|
|
Manufacturer Narrative
|
Sensor (b)(6)has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing were performed and all results were within specification.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.The freestyle librelink app complaint was investigated and determined that there were no issues with the librelink application that would have led to the complaint.The customer reported an error message was observed.The reported issue was investigated and attempted to replicate using similar configuration and the reported issue was unable to be replicated and the system functioned as intended.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A "replace sensor" error message was reported with the adc device in use with iphone 11, ios version unk, app version unk and customer was unable to obtain readings.As a result, customer felt nauseous and experienced vomiting.The customer was unable to self-treat, requiring a healthcare professional administration of intravenous glucose(dose unknown) for treatment.An hcp reading around 7 mmol was obtained and no further treatment was reported.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
The freestyle libre 2 app complaint was investigated and determined that there were no issues with the libre 2 application that would have led to the complaint.The customer reported signal loss.The reported issue was investigated and attempted to replicate using similar configuration and the reported issue was unable to be replicated and the system functioned as intended.Sensor (b)(6)has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing were performed and all results were within specification.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.This also serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A "replace sensor" error message was reported with the adc device in use with iphone 11, ios version unk, app version unk and customer was unable to obtain readings.As a result, customer felt nauseous and experienced vomiting.The customer was unable to self-treat, requiring a healthcare professional administration of intravenous glucose(dose unknown) for treatment.An hcp reading around 7 mmol was obtained and no further treatment was reported.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|
|