Model Number 71953-01 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
Burn(s) (1757)
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Event Date 03/31/2023 |
Event Type
Injury
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Event Description
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Customer reports their adc reader is too hot to hold and as a result, customer experienced a minor burn on their right arm, and ¿3rd degree burn¿ on their ¿index and little finger¿.It is unknown if the customer's device was too hot to hold during use or while charging.It is unknown at this time if the charging cable and adapter used was the cable and adapter supplied by adc for use with the libre device.There was no report of fire, smoke, explosion, or shock.There was no report of death or permanent impairment associated with this event.Issues involving thermal events occurring with adc freestyle libre and libre 2 readers is associated with report of corrections and removal number 2954323-02/09/23-001-c, submitted to the fda on (b)(6) 23.Adc field action fa1005-2023 was issued to the us (b)(6) 23.
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Manufacturer Narrative
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The customer's product has been requested for investigation.A follow-up report will be submitted once 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.All pertinent information available to abbott diabetes care has been submitted.
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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 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 and a valid serial number has not been provided.A valid lot or serial number was not provided; therefore, it is not possible to check dhr for cable and adapter.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.A tripped trend review was conducted for the reported complaint and libre reader, 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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Customer reports their adc reader is too hot to hold and as a result, customer experienced a minor burn on their right arm, and ¿3rd degree burn¿ on their ¿index and little finger¿.It is unknown if the customer's device was too hot to hold during use or while charging.It is unknown at this time if the charging cable and adapter used was the cable and adapter supplied by adc for use with the libre device.There was no report of fire, smoke, explosion, or shock.There was no report of death or permanent impairment associated with this event.Issues involving thermal events occurring with adc freestyle libre and libre 2 readers is associated with report of corrections and removal number 2954323-02/09/23-001-c, submitted to the fda on 09-feb-23.Adc field action fa1005-2023 was issued to the us 09feb23.
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Search Alerts/Recalls
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