STA COMPACT
Received Dec 26, 2013 · Event occurred Oct 14, 2013
Report 2245451-2013-00002 · MDR key 3560380
Device
Manufacturer
Diagnostica Stago, Inc.Catalog number
58986
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER DISCOVERED THAT THE LOT SPECIFIC INTERNATIONAL SENSITIVITY INDEX (ISI) VALUE DISPLAYED ON ONE OF HIS SIA COMPACT ANALYZERS WAS RESET TO 1.00 INSTEAD OF 1.32. THIS DEFECT WAS DUE TO AN OPERATOR ERROR AND RESULTED TO THE UNDERESTIMATION OF THE INTERNATIONAL NORMALIZED RATIO (INR) VALUE FOR 203 PATIENTS WHO HAD A PROLONGED PT TEST RESULT (INR > 1.5). THE CLINICAL PHARMACIST IDENTIFIED SOME PATIENTS WHEREIN DOSAGE OF TREATMENT HAD BEEN ADJUSTED BASED ON THOSE ERRONEOUS RESULTS. HOWEVER, ACCORDING TO THE CUSTOMER, NO DEATH OR SERIOUS INJURY HAS BEEN REPORTED TO DATE. REFERENCE MFR REPORT NUMBER: 8043723-2013-00002.