|
Model Number 100071 |
Device Problems
Device Expiration Issue (1216); Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/17/2015 |
Event Type
malfunction
|
Event Description
|
The caller alleged unexpected inratio inr results.Results are as follows: (b)(6).The caller stated that she wanted to be at a therapeutic range of 2.5.She provided a lot number that could not be verified.In addition, she reported that the strips, that she was using, showed that they had expired in (b)(6) 2014.The caller was unwilling to complete troubleshooting.There was no reported adverse patient sequela.There was no additional information provided.
|
|
Manufacturer Narrative
|
As of this date ((b)(6)2015), further investigation cannot be pursued because there is no monitor return, and the strip lot number that was provided was invalid.If the product lot number or monitor is received, the device will be investigated and a follow up report will be submitted.The customer was using expired strips for testing and is considered off label use.The use of expired strips may be a cause for the errors experienced by the customer.
|
|
Search Alerts/Recalls
|
|
|