| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AXSYM DRUGS FOR ABUSE TOXICOLOGY ASSAY DISK | AMPHETAMINE TEST SYSTEM | ABBOTT LABORATORIES | MGX | NA | 3D54-08 | NA | N | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-03-06 | 0 |
Patient 1
THE CUSTOMER STATED THAT VRTX ERROR 002 IN TASK 40 OCCURRED ON THE AXSYM ANALYZER AFTER EDITING THE CUTOFF PARAMETERS FOR AMPHETAMINES. AXSYM SYSTEM SOFTWARE VERSION 8.0 WAS INSTALLED ON THE ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient 1
A NEW AXSYM DRUGS OF ABUSE (DOA)/TOXICOLOGY ASSAY DISK (VERSION 8.0) WAS RELEASED CONTAINING AN UPDATED VERSION OF THE AXSYM AMPHETAMINE/METHAMPHETAMINE II ASSAY FILE. THIS FILE WAS CREATED USING AXSYM OFFLINE SOFTWARE VERSION 6.0. WHEN CUSTOMERS ATTEMPTED TO EDIT THE AXSYM AMPHETAMINE/ METH-AMPHETAMINE II POSITIVE AND NEGATIVE INTERPRETATION CUTOFFS AFTER INSTALLING THE UPDATED ASSAY FILE, THEY OBSERVED AN AXSYM SYSTEM VRTX ERROR #002 IN TASK 40 WHEN RUNNING PATIENT SAMPLES. THE VRTX ERROR CAUSES THE INSTRUMENT TO LOCK UP. THROUGH THE ANALYSIS OF EXISTING DATA AND THE PRELIMINARY INVESTIGATION ASSOCIATED WITH THE RISK EVALUATION, THE ROOT CAUSE WAS IDENTIFIED TO BE A CHANGE IN THE AXSYM OFFLINE SOFTWARE. AXSYM OFFLINE SOFTWARE VERSION 6.0 REPLACED VERSION 5.9.0. THE PARAMETERS IN AXSYM OFFLINE SOFTWARE VERSION 5.9.0 CONTAINED 31 CHARACTERS WHILE THE PARAMETERS IN AXSYM OFFLINE SOFTWARE VERSION 6.0 CONTAINED 47. THE OFFLINE SOFTWARE PADS THESE EXTRA FIELDS WITH SPACES. WHEN THE CUSTOMER EDITS THE POSITIVE AND NEGATIVE INTERPRETATION CUTOFFS THE CHARACTERS FROM THESE FIELDS ARE PUSHED INTO THE NEXT FIELDS, THE NEGATIVE RECALCULATION INTERPRETATION FORMULA AND THE POSITIVE INTERPRETATION HOLD OPTION PARAMETERS. WHEN AN AMPHETAMINE RESULT IS GENERATED, THE AXSYM SYSTEM SOFTWARE ATTEMPTS TO INTERPRET THE RESULT. BECAUSE SPACE CHARACTERS HAVE BEEN PUSHED FROM THE POSITIVE AND NEGATIVE INTERPRETATION CUTOFF PARAMETERS INTO THE INTERPRETATION FORMULA AND HOLD OPTION PARAMETERS, THE AXSYM SOFTWARE CANNOT MAKE A DECISION AND THE VRTX ERROR IS GENERATED. ON 01/10/08, THE DOA/TOXICOLOGY ASSAY DISK WAS PUT ON QUALITY HOLD. A NEW DISK WILL BE RELEASED TO THE FIELD USING AXSYM OFFLINE SOFTWARE VERSION 5.9.0. NO LATER THAN 3/31/08, WHICH WILL HAVE ADDRESSED THE ISSUE IN AXSYM OFFLINE SOFTWARE VERSION 6.0. THIS IS THE FINAL REPORT. END OF REPORT.