|
Model Number 100071 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/26/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation is pending.
|
|
Event Description
|
The following information was reported via telephone call on (b)(6) 2016.Results are as follows: date: (b)(6) 2016, inratio inr: 2.0; (b)(6) 2016, 2.1; (b)(6) 2016, 1.4 and 1.6 (<15 minues apart).Therapeutic range: 2.0 - 3.0.Reportedly, multiple finger sticks were performed on the same finger and multiple drops of blood added to the sample well.This is considered to be improper techniques when performing the inratio test.There was no reported adverse patient sequela.There was no additional information provided.
|
|
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 accuracy criteria.The product performed as expected.The customer's complaint was not replicated.Although a relevant nc was noted in batch record, it did not affect the final release specifications.There is no indication of a product deficiency and additional corrective actions were not required.The customer did not provide a laboratory alternative testing method result for the reported inratio value.It is not possible to verify if a discrepancy exists without this information.Although the root cause analysis did not include return testing, improper techniques were identified in the complaint.These could not be ruled out as a cause of the unexpected results.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
|
|
Search Alerts/Recalls
|
|
|