Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912); Blurred Vision (2137); Diaphoresis (2452)
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Event Date 11/26/2023 |
Event Type
Injury
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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.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.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 high readings issue with the adc device was reported.Customer received unspecified higher sensor scan results compared to unspecified readings obtained on hcp meter.As a result, customer experienced sweating, asthenia, vision trouble and was treated with oral glucose, biscuits, grape juice by a healthcare professional for treatment.An hcp meter reading of 100mg/dl was also obtained, the time of this reading was unspecified in relation to treatment.No further treatment was reported.There was no report of death or permanent impairment associated with this event.Sensor results of 280 mg/dl and 197 mg/dl was compared to a hcp meter readings of 130 mg/dl and 100 mg/dl respectively and the results, when plotted on a parkes error grid, fall into the "c" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.
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Event Description
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A high readings issue with the adc device was reported.Customer received unspecified higher sensor scan results compared to unspecified readings obtained on hcp meter.As a result, customer experienced sweating, asthenia, vision trouble and was treated with oral glucose, biscuits, grape juice by a healthcare professional for treatment.An hcp meter reading of 100mg/dl was also obtained, the time of this reading was unspecified in relation to treatment.No further treatment was reported.There was no report of death or permanent impairment associated with this event.Sensor results of 280 mg/dl and 197 mg/dl was compared to a hcp meter readings of 130 mg/dl and 100 mg/dl respectively and the results, when plotted on a parkes error grid, fall into the "c" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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