Model Number 72081-01 |
Device Problem
Failure to Fire (2610)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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This complaint was received via user report and has been reported to fda.Extended investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or additional information is obtained.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.This is submission report 10 of 10.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Abbott diabetes care received a medwatch report which reported the following information: a customer reported that the adc device did not fire (did not apply) during the sensor application, therefore, was unable to obtain sensor readings.No further information was provided, there was no report of any self or third-party medical treatment reported.Adc customer service contacted the customer and they stated that they "had already called to report, but was told that there was a limit amount of replacements for 6 months, so far he has had 10 replacements".Based on the information provided, there was no report of serious injury associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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 functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.At this time product has not yet been returned for this complaint and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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.
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Event Description
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Abbott diabetes care received a medwatch report which reported the following information: a customer reported that the adc device did not fire (did not apply) during the sensor application, therefore, was unable to obtain sensor readings.No further information was provided, there was no report of any self or third-party medical treatment reported.Adc customer service contacted the customer and they stated that they "had already called to report, but was told that there was a limit amount of replacements for 6 months, so far he has had 10 replacements".Based on the information provided, there was no report of serious injury associated with this event.
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Search Alerts/Recalls
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