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Model Number 100071 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Investigation/conclusion: since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "obtained inaccurate readings on inratio meter - hospitalized due to blood loss" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.If additional information is received, a supplemental medwatch form will be completed and submitted.
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Event Description
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This event was identified as part of an evaluation in which insurance claims/filed suits communicated to alere legal had not been forwarded to alere (b)(4) for investigation.There is limited information available regarding the event and due to the time gap between when the complaint was first reported to when alere (b)(4) was notified, additional information is not available.Complainant alleged that patient "obtained inaccurate readings on inratio meter - hospitalized due to blood loss." there were no inr results, event description or event date reported.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of alleged event.Based on the inability to rule out the possibility that the device may have caused or contributed to the "obtained inaccurate readings on inratio meter - hospitalized due to blood loss" allegation, this event is conservatively reported as a serious injury; however, a device deficiency cannot be substantiated.
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Search Alerts/Recalls
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