Model Number 72081-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
|
Patient Problems
Hyperglycemia (1905); Dizziness (2194)
|
Event Date 04/05/2024 |
Event Type
Injury
|
Event Description
|
A scan again in 10 minutes error message was reported with the abbott diabetes care (adc) device and the customer was unable to obtain readings.As a result, the customer experienced symptoms described as cold, dizzy, and a loss of consciousness and was able to self-treat with insulin.There was no third party treatment 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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre 2 sensors, and a trend was investigated where a probable root cause was related to an insertion issue.However without a valid sensor number or product return, the root cause of the particular issue associated with this complaint is unknown and cannot be further determined.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
|
|
Manufacturer Narrative
|
This serves as a correction report.Section(s) updated as follows: b1: updated to adverse event from product problem.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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre 2 sensors, and a trend was investigated where a probable root cause was related to an insertion issue.However without a valid sensor number or product return, the root cause of the particular issue associated with this complaint is unknown and cannot be further determined.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A scan again in 10 minutes error message was reported with the abbott diabetes care (adc) device and the customer was unable to obtain readings.As a result, the customer experienced symptoms described as cold, dizzy, and a loss of consciousness and was able to self-treat with insulin.There was no third party treatment reported.There was no report of death or permanent impairment associated with this event.
|
|
Manufacturer Narrative
|
Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software, and extraction was successful.Data analysis was consistent with the removal of a properly applied and functioning sensor.Sensor state 7 with event code 11 and sensor state 8 with event code 9 are an indication that the sensor had terminated due to an intentional non-fatal error recognized by the sensor.This termination is an intended part of the sensors system and is not an indication of product non-conformance as the data is consistent with a removal of a properly applied sensor.As a result, the sensor had recognized its removal and had terminated in which the sensor was working as intended.Data quality errors are not customer facing and occurs to protect the user from unreliable glucose values by not presenting the values to the user.These indicate brief physiological issues (such as rapidly changing glucose due to food or exercise) that are not indicative of a product failure since the sensor was able to recover and continue to provide accurate glucose results.Therefore, 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.Section d4 (serial number) was updated from (b)(6) to (b)(6).All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
A scan again in 10 minutes error message was reported with the abbott diabetes care (adc) device and the customer was unable to obtain readings.As a result, the customer experienced symptoms described as cold, dizzy, and a loss of consciousness and was able to self-treat with insulin.There was no third party treatment reported.There was no report of death or permanent impairment associated with this event.
|
|
Search Alerts/Recalls
|
|