Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Material Twisted/Bent (2981)
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Patient Problems
Diaphoresis (2452); Shaking/Tremors (2515)
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Event Date 12/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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The reported product is not expected to be returned as reporter indicated the device was discarded.Physical investigation of product is not anticipated as reporter indicated device was discarded.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of all required investigation activities.The device mfg date is unknown.The date entered in 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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A customer reported a bent adc freestyle libre 2 sensor tip.As a result, on (b)(6) 2021, the customer experienced sweating, shaking, and being off balance and was unable to treat themselves.The customer self-presented at an emergency room where an unknown lab glucose result was obtained and he received unspecified treatment to control glycemic and for dehydration.The customer further reported being hospitalized through (b)(6) 2021.No further information was reported.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.No product has been returned and a valid serial number has not been provided.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 the freestyle 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 libre sensor, 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.Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
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Event Description
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A customer reported a bent adc freestyle libre 2 sensor tip.As a result, on 26dec2021, the customer experienced sweating, shaking, and being off balance and was unable to treat themselves.The customer self-presented at an emergency room where an unknown lab glucose result was obtained and he received unspecified treatment to control glycemic and for dehydration.The customer further reported being hospitalized through 31dec2021.No further information was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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