Model Number 07P4830 |
Device Problem
Low Test Results (2458)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/01/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
|
|
Event Description
|
A physician questioned alinity i tsh results for a (b)(6) year old female patient.The result in (b)(6) 2020 was 4.766 miu/ml.The result in february was 7.870 miu/ml.The samples were not retested.(b)(6) result 4.766 miu/ml.(b)(6) result 7.870 miu/ml.The customer uses a normal range of 0.35 - 4.94 miu/ml.The physician questioned the difference between results in a short time period since the patient had not taken any medication.No additional testing was performed to determine whether either of the results were incorrect.No adverse impact to patient management was reported.
|
|
Manufacturer Narrative
|
No customer returns were available.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Manufacturing documentation was reviewed and no contributing factors to the complaint could be identified.Testing was performed using an in-house retained kit and all specifications were met indicating the lot is preforming acceptably.Based on the available information, no product deficiency was identified.
|
|
Search Alerts/Recalls
|