| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT C8000 SYSTEM | ABBOTT MANUFACTURING INC | MZV | 01G06-11 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-11-01 | 0 |
Patient 1
THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED A HIGHER THAN EXPECTED RESULT OF 7.4 MMOL/L FOR THE POTASSIUM ASSAY FROM ONE PATIENT SAMPLE. A NEW SAMPLE FROM THE SAME PATIENT WAS THEN TESTED WITH A NON-ABBOTT DEVICE AND A RESULT OF 4.3 MMOL/L WAS OBTAINED WITH NO IMPACT TO THE PATIENT OVERALL HEALTH.
Patient 1
THIS REPORT REFERENCES REPORT NUMBER 1628664-2013-00284 WHICH WAS INITIALLY SUBMITTED AGAINST THE CC CREATININE ASSAY AND THE EVALUATION RESULTS FOR THE DISCREPANT CREATININE RESULTS WILL BE SUBMITTED THROUGH A FOLLOW-UP REPORT TO MDR NUMBER 1628664-2013-00284. THE CURRENT MDR (1628664-2013-00298) IS BEING SUBMITTED AGAINST A NEWLY IDENTIFIED SUSPECT DEVICE TO ADDRESS THE DISCREPANT POTASSIUM RESULTS GENERATED FROM THE SAME PATIENT AND PREVIOUSLY REPORTED UNDER MDR NUMBER 1628664-2013-00284 THE DISCREPANT POTASSIUM RESULTS ISSUE WILL BE INVESTIGATED UNDER THIS CURRENT MDR 1628664-2013-00298. PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT
Patient 1
PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THE ISSUE. THE COMPLAINT INDICATES A SINGLE SAMPLE TESTED ON ARCHITECT (B)(4) GENERATED A DISCREPANT HIGH K RESULT OF 7.4 MMOL/L AND WHEN THE SAMPLE WAS RE-TESTED ON A ROCHE C6000 SYSTEM THE RESULT WAS NORMAL, 4.3 MMOL/L. THE SAMPLE WAS NOT RETESTED ON (B)(4). NO OTHER SAMPLES OR ASSAY RESULTS ARE IMPLICATED. NO INSTRUMENT TROUBLESHOOTING WAS PERFORMED AND THE SERVICE HISTORY DOES NOT INCLUDE ADDITIONAL REPORTS OF DISCREPANT K RESULTS. A REVIEW OF C8000 AND ICT MODULE TRACKING AND TRENDING DID NOT IDENTIFY ANY ADVERSE TRENDS RELATED TO ERRATIC AND/OR ELEVATED ICT K RESULTS. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION RELATED TO HANDLING SPECIMENS AND CONSUMABLES, REQUIRED MAINTENANCE, AND TROUBLESHOOTING THE REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION A SINGULAR DEFINITIVE CAUSE OF THE DISCREPANT HIGH K RESULTS WAS NOT IDENTIFIED. AN ISSUE WITH THE SUSPECT SAMPLE INTEGRITY COULD NOT BE RULED OUT. THE ISSUE WAS ISOLATED TO A SINGLE SAMPLE. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT A DEVICE MALFUNCTION CAUSED THE DISCREPANT HIGH K RESULT. BASED ON THE INVESTIGATION RESULTS, A DEFICIENCY IS NOT IDENTIFIED.