Model Number 75175-83 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 10/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time, product has not yet been returned.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.A valid lot or serial number was not provided for test strips.The dhrs (device history record) for the freestyle optium neo h meter, and the dhrs showed the freestyle optium neo h meter passed all tests prior to release.Clinical data was reviewed and confirmed that precision strips continue to be safe, effective, and perform as intended in the field.Stability data for precision strips 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 precision strips; no trends were identified that would indicate any product related issues.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A high glucose results issue was reported with an adc hospital meter.It was reported that a patient was admitted into hospital unresponsive and seizing.At 0600, a blood glucose result of 22.3 mmol/l was obtained on the adc meter and at 0615, blood was collected for laboratory analysis.Results of this analysis (returned at 0722) showed that the customer had a blood glucose of 0.8 mmol/l at this time.Approximately an hour later, at 0709, another blood glucose result of 5.2 mmol/l was obtained from meter, and at this time the patient was started on 4% glucose/0.18% saline infusion via iv.Intubation was also done at this time.At 0727 a blood glucose result of lo (< 1.1 mmol/l) was obtained from meter.The patient was admitted to icu, but the healthcare professional indicated that this was due to an issue separate from patient's hypoglycemic episode.It was additionally noted that the patient's hypoglycemia was result of insulin overdose.No further details were obtained.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The returned meter was investigated with retained test strips.Visual inspection was performed on returned meter.No issues observed.Meter powered on with button depression and cal bar or strip insertion.Low and high control solution testing was performed and the control solution test was satisfactory.Blank screen was not observed.The complaint was not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A high glucose results issue was reported with an adc hospital meter.It was reported that a patient was admitted into hospital unresponsive and seizing.At 0600, a blood glucose result of 22.3 mmol/l was obtained on the adc meter and at 0615, blood was collected for laboratory analysis.Results of this analysis (returned at 0722) showed that the customer had a blood glucose of 0.8 mmol/l at this time.Approximately an hour later, at 0709, another blood glucose result of 5.2 mmol/l was obtained from meter, and at this time the patient was started on 4% glucose/0.18% saline infusion via iv.Intubation was also done at this time.At 0727 a blood glucose result of lo (< 1.1 mmol/l) was obtained from meter.The patient was admitted to icu, but the healthcare professional indicated that this was due to an issue separate from patient's hypoglycemic episode.It was additionally noted that the patient's hypoglycemia was result of insulin overdose.No further details were obtained.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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