Model Number 72081-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Diaphoresis (2452); Confusion/ Disorientation (2553)
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Event Date 01/24/2024 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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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Event Description
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An unspecified error message was reported with the adc device, and the customer was unable to obtain readings.As a result, the customer experienced hypoglycemia, paleness, sweatiness, and confusion and was unable to self-treat.The customer was taken to the hospital, where a healthcare professional determined the glucose value (glucose value not provided) and was diagnosed with hypoglycemia.It is unknown if any treatment or medication was provided.Adc customer service is currently in the process of making additional attempts to gain further information, and a follow-up will be submitted when more information is obtained.There was no report of death or permanent impairment 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 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.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 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.
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Event Description
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An unspecified error message was reported with the adc device, and the customer was unable to obtain readings.As a result, the customer experienced hypoglycemia, paleness, sweatiness, and confusion and was unable to self-treat.The customer was taken to the hospital, where a healthcare professional determined the glucose value (glucose value not provided) and was diagnosed with hypoglycemia.It is unknown if any treatment or medication was provided.Adc customer service is currently in the process of making additional attempts to gain further information, and a follow-up will be submitted when more information is obtained.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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