Model Number 100071 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Issue (2379)
|
Patient Problems
Transient Ischemic Attack (2109); Blurred Vision (2137); No Consequences Or Impact To Patient (2199)
|
Event Date 04/17/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
Investigation conclusion: investigation pending.
|
|
Event Description
|
Report received of discrepant inratio value.(b)(6).Patient went to hospital due to blurred/double vision on (b)(6) 2016.Patient admitted to hospital for tia.Released from hospital on (b)(6) 2016, no medication given, no changes in medication.Patient's therapeutic range 2.0-3.0 prior to hospitalization and tia.Patient's new therapeutic range 2.5-3.5.
|
|
Manufacturer Narrative
|
Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house strip testing on the reported strip lot meets release criteria.The customer's complaint was not replicated and no product deficiency was identified.A review of the manufacturing batch records for the reported strip lot did not uncover any non-conformances.The lot met release specifications.Root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
|
|
Search Alerts/Recalls
|