Model Number 71501-01 |
Device Problem
Crack (1135)
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Patient Problems
Hyperglycemia (1905); Weakness (2145); Dizziness (2194); Loss of consciousness (2418)
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Event Date 01/10/2019 |
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 date of event is unknown.The device mfg date is unknown.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Caller reported that the customer's adc blood glucose meter was broken and was therefore unable to test.On an unspecified date, customer experienced dizziness, weakness, was unstable on her feet and subsequently lost consciousness.Customer was seen at the hospital where she was diagnosed with hyperglycemia and treated with insulin (dose and type unknown), insulin glulisine, lantus (insulin glargine), cefdinir (antibiotic) and unspecified pills for hypertension.Customer was still in the hospital during the time of call.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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No product has been returned and a valid sensor 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.Dhrs (device history review) for all freestyle lite meters within expiration at the time of complaint were reviewed, and the dhr review showed no there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint. a tripped trend review was completed for the reported complaint, there were no adverse trend identified.If the product is returned, the case will be re-opened, and a physical investigation will be performed.
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Event Description
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Caller reported that the customer's adc blood glucose meter was broken and was therefore unable to test.On an unspecified date, customer experienced dizziness, weakness, was unstable on her feet and subsequently lost consciousness.Customer was seen at the hospital where she was diagnosed with hyperglycemia and treated with insulin (dose and type unknown), insulin glulisine, lantus (insulin glargine), cefdinir (antibiotic) and unspecified pills for hypertension.Customer was still in the hospital during the time of call.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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