COBAS 8000 MODULAR ANALYZER SERIES

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED FOR PATIENT SAMPLE 1 AFFECTING THE FOLLOWING MEDWATCH FIELDS: (B)(6). SEX WAS MALE. (B)(4). DATE OF EVENT WAS ACTUAL (B)(6) 2011 NOT (B)(6) 2011 AS PREVIOUSLY REPORTED. DATE RECEIVED BY MANUFACTURER WAS (B)(4) 2011 NOT (B)(4) 2011 AS PREVIOUSLY REPORTED. THE ERRONEOUS CALCIUM RESULT WAS REJECTED BY THE LAB EXPERT AND THE TEST WAS REPEATED. THE RESULTS OF 9.6 MG/DL WAS REPORTED OUTSIDE THE LABORATORY.

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THIS ISSUE MAY BE A CUSTOMER SPECIFIC PROBLEM. ALTHOUGH INTENSIVE MAINTENANCE ACTIONS WERE PERFORMED, THE PROVEN REAGENT CARRY-OVER FROM MAGNESIUM COULD NOT BE ELIMINATED. THIS PHENOMENON SEEMED TO BE RELATED TO THIS INDIVIDUAL INSTRUMENT AND IT WAS ASSUMED THAT THE WASHING ACCURACY WAS WEAK. TO SOLVE THE INTERMITTENT ISSUE, AN EXTRA WASH BETWEEN MAGNESIUM AND CALCIUM WAS INTRODUCED WHICH SOLVED THE ISSUE. NO ADVERSE EVENTS WERE REPORTED.

Description of Event or Problem

THE USER EXPERIENCED IMPRECISION FOR THE CALCIUM ASSAY AND PERFORMED A PRECISION CHECK WITH PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR 10 PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE IN MG/DL. THE EXACT DATE OF TESTING WAS NOT PROVIDED FOR THE FOLLOWING SAMPLES. THE REPEAT TESTING WAS PERFORMED ON THE INTEGRA 800 ANALYZER. THE CALCIUM REAGENT LOT NUMBER USED FOR THESE SAMPLES WAS 632822. PATIENT SAMPLE 1 INITIAL RESULT WAS 6.2 AND THE REPEAT RESULT WAS 9.6. PATIENT SAMPLE 2 INITIAL RESULT WAS 7.1 AND THE REPEAT RESULT WAS 10.0. PATIENT SAMPLE 3 INITIAL RESULT WAS 7.4 AND THE REPEAT RESULT WAS 10.2. PATIENT SAMPLE 4 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 10.1. PATIENT SAMPLE 5 INITIAL RESULT WAS 8.0 AND THE REPEAT RESULT WAS 10.2. THE FOLLOWING PATIENT SAMPLES WERE TESTED ON (B)(6) 2011. THE REPEAT TESTING WAS PERFORMED ON THE COBAS 8000. THE CALCIUM REAGENT LOT NUMBER USED FOR THESE SAMPLES WAS 638401. PATIENT SAMPLE 6 INITIAL RESULT WAS 5.8 AND THE REPEAT RESULT WAS 10.0. PATIENT SAMPLE 7 INITIAL RESULT WAS 6.0 AND THE REPEAT RESULT WAS 10.1. PATIENT SAMPLE 8 INITIAL RESULT WAS 7.6 AND THE REPEAT RESULT WAS 9.9. PATIENT SAMPLE 9 INITIAL RESULT WAS 6.2 AND THE REPEAT RESULT WAS 9.0. PATIENT SAMPLE 10 INITIAL RESULT WAS 6.7 AND THE REPEAT RESULT WAS 10.1. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE.