MTS READER M

Additional Manufacturer Narrative

THE CUSTOMER WAS PERFORMING A/B/O TEST PREPARATION ON THE TECAN MEGAFLEX ID ROBOTIC PIPETTOR AND EVALUATING THE RESULTS WITH THE MTS READER M. THE CUSTOMER REPORTED A MISTYPED SAMPLE. A DISCREPANCY WAS FOUND BETWEEN THE PIPETTING INSTRUMENT AND THE READER M. MTS WAS UNABLE TO RECREATE THE CUSTOMER ISSUE. CUSTOMER ERROR COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. INSTRUMENT MALFUNCTION COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. HOWEVER, EACH READING AND FINAL TEST RESULT MUST BE REVIEWED AND ACCEPTED BY A TECHNOLOGIST BEFORE IT CAN BE STORED, PRINTED OR TRANSMITTED BY THE READER M. BECAUSE THE CORRECT MATCHING OF ABO GROUP BETWEEN DONOR BLOOD AND A PT IS CRITICAL TO TRANSFUSION SAFTY, THE RISK ATTENDANT TO AN INDIVIDUAL ERRONEOUS RESULT IS SIGNIFICANTLY LESSENED BY LAB PRACTICES AND REGULATIONS THAT REQUIRE THAT ABO GROUPING BE ESTABLISHED BY MORE THAN ONE TEST RESULT AND BY REFERENCE TO HISTORICAL RESULTS. ABO SERUM OR PLASMA TESTS SHOULD ALWAYS BE PERFORMED AS AN ADJUNCT TO ABO CELL GROUPING TESTS. IF THE ALLEGED MALFUNCTION WERE TO RECUR, ADD'L TESTING WILL BE CONDUCTED TO VERIFY ABO TYPE, PREVENTING THE MISCLASSIFICATION OF PT/DONOR ABO TYPE. NO ERRONEOUS RESULT WERE REPORTED BY THE CUSTOMER. THE LIKELIHOOD OF A SERIOUS INJURY, WHILE NOT FREQUENT, IS NOT REMOTE. MTS IS REPORTING THIS EVENT BASED ON THE POTENTIAL FOR INJURY SHOULD THE EVENT RECUR WITHOUT DETECTION BY THE USER.

Description of Event or Problem

A SAMPLE WAS TYPED INCORRECTLY WHILE PERFORMING A/B/O TESTING ON THE MTS READER M.