THE ABBOTT M2000 REALTIME SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP INSTRUMENT IS AN AUTOMATED FLUID HANDLING SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT SYSTEM SOFTWARE IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR THAT RESULTS IN QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. A CUSTOMER EXPERIENCED MULTIPLE ERROR MESSAGES FROM THE ABBOTT M2000RT INSTRUMENT. AN ABBOTT MOLECULAR FIELD SERVICE ENGINEER INSPECTED THE INSTRUMENT AND FOUND THE RED AND BLACK WIRES FROM THE BLOCK TO THE POWER AMPLIFIER WERE SLIGHTLY MELTED. THE POWER AMPLIFIER BOARD, THE BLOCK DRIVE ASSEMBLY WHICH INCLUDES THE HEATED COVER, AND THE GEMINI BOARD WERE REPLACED. THE INSTRUMENT WAS RELEASED TO THE CUSTOMER. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT WAS REGISTERED FOR EVIDENCE OF OVERHEATING. AN INVESTIGATION IS IN PROGRESS. IT IS UNKNOWN AT THIS TIME IF THIS OBSERVATION WAS CAUSED BY AN ABBOTT PRODUCT MALFUNCTION. IF A PRODUCT MALFUNCTION IS IDENTIFIED THEN FURTHER EVALUATION WILL DETERMINE IF RECURRENCE OF THE MALFUNCTION COULD CAUSE DEATH OR SERIOUS INJURY.
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Patient 1
SUMMARY OF COMPLAINT INVESTIGATION FOR MDR 3005248192-2014-00001_FOLLOW-UP REPORT 1: PROBLEM: A FSE WAS ALERTED TO THE MULTIPLE ERROR CODES (6267, 6288, 6084, 6218, 6229) FROM A CUSTOMER ACCOUNT IN (B)(6) VIA ABBOTT LINK. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT THE RED AND BLACK WIRES FROM BLOCK TO THE PCA POWER AMPLIFIER BOARD SHOWED EVIDENCE OF OVERHEATING AT CONNECTOR TB1 ON THE POWER AMPLIFIER BOARD. THE FSE ALSO STATED ALL FUSING WAS INTACT AND NO SMOKE OR SOOT WAS OBSERVED EXTERNAL OF THE SUSPECT M2000RT INSTRUMENT. CONCLUSION: BASED ON INSPECTION AND AVAILABLE INFORMATION, THE OVERHEATING WAS LOCALIZED TO CONNECTOR TB1 ON THE PCA POWER AMPLIFIER BOARD. THE OVERHEATING AT TB1 WAS DUE TO THE COPPER HEATING ELEMENT TRACE IN THE HEATED COVER VERSION 1 SHORTING TO ONE OF THE MOUNTING SCREWS AS SHOWN IN FIGURE 7. IT APPEARS THAT THE DAMAGED COPPER HEATING ELEMENT TRACE OPENED INSTEAD OF THE PROTECTIVE FUSING. NO SMOKE OR SOOT WAS OBSERVED EXTERNAL TO THE SUSPECT M2000RT INSTRUMENT AND THE OVERHEATING WAS CONTAINED WITHIN THE M2000RT METAL ENCLOSURE. ON-SITE SERVICE, CONSISTING OF REPLACEMENT OF THE BLOCK DRIVE ASSEMBLY (WHICH CONTAINS THE NEW HEATED COVER VERSION 2), PCA POWER AMPLIFIER BOARD AND THE PCA MICROCONTROLLER, RESTORED THE M2000RT TO OPERATIONAL STATUS. PROPER ENGINEERING CONTROLS WERE IN PLACE TO PREVENT INJURY TO THE OPERATOR FROM EXPOSURE TO POTENTIAL FIRE. ELECTRICAL COMPONENT CHARRING AND MELTING WAS COMPLETELY CONTAINED INSIDE OF THE METALLIC M2000RT ENCLOSURE, PER THE REQUIREMENTS OF THE REFERENCED SAFETY STANDARDS. THE M2000 OPERATIONS MANUAL CONTAINS REFERENCES TO ALL OF THE APPLICABLE SAFETY STANDARDS FOR THE M2000 SYSTEM. VALID MATERIAL SPECIFICATIONS ARE RESIDENT IN THE ABBOTT MOLECULAR QUALITY SYSTEM FOR THE M2000RT, ASSY, BLOCK DRIVE AIRJUICE, PCA POWER AMPLIFIER BOARD, AND THE PCA MICROCONTROLLER. COMPLAINT HISTORY REVIEW SHOWED THAT, OVER THE LAST TWO YEARS, THE SUSPECT COMPLAINT WAS FOUND TO BE THE ONLY COMPLAINT RELATED TO INSTANCES OF THE WIRES FROM THE BLOCK TO POWER AMP BOARD OVERHEATING. THEREFORE, WE HAVE AN OCCURRENCE RATE OF ONE OVER THE LAST TWO YEARS. BASED-UPON THE AVAILABLE DATA, THE PCA POWER AMPLIFIER BOARD FAILED AS DESIGNED AND THERE IS NO PRODUCT DEFICIENCY. THEREFORE, THIS COMPLAINT IS UNCONFIRMED.