Catalog Number 09315276160 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/29/2024 |
Event Type
malfunction
|
Event Description
|
The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys probnp ii (probnp ii) on a cobas e 601 module.The initial result was < 36 pg/ml with a data flag.This result was reported outside of the laboratory where the doctor requested repeat testing as the result did not correspond to the patient¿s clinical picture.The repeat result was 11890 pg/ml.This result was believed to be correct.The sample was repeated for confirmation on the other line of the e601 module and the result was 11458 pg/ml.
|
|
Manufacturer Narrative
|
The e601 module serial number was (b)(6).
|
|
Manufacturer Narrative
|
Section d, device identification was updated.Relevant fields of sections d and g were updated.The probnp ii reagent lot number was 72243101 with an expiration date of 31-aug-2024.The field service engineer (fse) visited the customer site and indicated there was a sample quality issue.Probnp precision results were within range and instrument performance testing was acceptable.Calibration was last performed on 23-jan-2024 with acceptable results.Qc was acceptable.There is no indication of a reagent or instrument performance issue.The customer used a centrifugation time of 5 minutes at 5000 revolutions per minute (rpm).Based on the customer's sample tube type, this time is too short and the speed is too fast.Procell/cleancell short alarms and sample short alarms were observed on the alarm trace data.The sample short alarms indicate poor sample quality.Based on the information provided, the investigation determined the event was consistent with preanalytical handling issues.
|
|
Search Alerts/Recalls
|