Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Fatigue (1849); Hemorrhage/Bleeding (1888); Nausea (1970); Shaking/Tremors (2515)
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Event Date 11/11/2023 |
Event Type
Injury
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Event Description
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A low readings issue was reported with the adc device.A customer reported receiving unspecified low sensor readings and as a result, customer experienced feeling nauseous, weak, shaky, and was bleeding.Customer had contact with a healthcare professional (hcp) who provided unspecified treatment and obtained a blood glucose reading of 118 mg/dl.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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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.A valid lot or serial number was not provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A stability and clinical review has been conducted and has found no indication of any product stability performance issues or clinical performance issues that could have led to the complaint.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.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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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A low readings issue was reported with the adc device.A customer reported receiving unspecified low sensor readings and as a result, customer experienced feeling nauseous, weak, shaky, and was bleeding.Customer had contact with a healthcare professional (hcp) who provided unspecified treatment and obtained a blood glucose reading of 118 mg/dl.There was no report of death or permanent 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 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 libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.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.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.If the product is returned, a physical investigation will be performed and a follow up report submitted.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the initial report.The correction has been made here.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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