ABBOTT M2000SP
Report
- Report Number
- 3005248192-2012-00011
- Event Type
- Malfunction
- Date Received
- February 23, 2012
- Date of Event
- January 27, 2012
- Report Date
- January 27, 2012
- Manufacturer
- ABBOTT MOLECULAR, INC.
- Product Code
- JQW
- PMA / PMN Number
- K092705
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
ABBOTT MOLECULAR HAS TAKEN A FIELD ACTION ((B)(4)) TO ADDRESS THIS ISSUE. ((B)(4)) HIGHLIGHTS THE ROOT CAUSE OF THE ISSUE. THE FOLLOWING MDRS WERE ALSO FILED: MDR 3005248192-2011-00012, 00014, 00015, 00016, 00017, 00018, 00019, 00020, 00021, 00022, 00024, 00025, 00026, 00027, 00028, 00029, 00030, 00031, 00032, 00034, 00035, MDR 3005248192-2012-00001, 00002, 00003, 00007. EXECUTIVE SUMMARY: ON 09/27/2011 IN A CLINICAL LABORATORY IN (B)(4), THE LIQUID WASTE SENSOR (PN 619777) CAUGHT LOCALIZED FIRE WITHIN THE LOWER CABINET OF AN M2000SP INSTRUMENT (LN 9K14-01) DURING THE ROUTINE OPERATION. THE FIRE BURNT THE SENSOR AND A PART OF THE LIQUID WASTE CONTAINER. IT WAS PUT OUT BY THE OPERATOR WITHOUT CAUSING OTHER DAMAGES OR INJURY. (B)(4). REQUIREMENT: PER M2000 INSTRUMENT SYSTEM USER NEEDS DOCUMENT (AM0035), "USERS NEED THE SYSTEM TO BE SAFE TO OPERATE. SAFE OPERATION ENCOMPASSES ELECTRICAL, PHYSICAL, AND BIOLOGICAL HAZARDS." (UN140). THE M2000SP INSTRUMENT WITH THE DAMAGED CABINET AND PARTS WERE RETURNED TO THE INSTRUMENT MFR TECAN (B)(4). TECAN CONDUCTED CAUSE INVESTIGATION FOR THE INCIDENT AND THE REPORT WAS SUBMITTED TO ABBOTT MOLECULAR ON 10/19/2011, KEPT WITH SUPPLIER CAPA RECORD (B)(4). THE REPORT IDENTIFIED THE FOLLOWING ROOT CAUSES FOR THE INCIDENT. IN INSTRUMENT MFG OPERATION OR THE INSTRUMENT SERVICING PROCESS OVERTIGHTENING OF THE SCREWS THAT MOUNT THE LIQUID WASTE SENSOR MAY CAUSE CRACKS IN THE SENSOR HOUSING OR SENSOR WINDOW. ETHANOL OR DETERGENTS USED BY THE CUSTOMER OR THE SERVICE PERSONNEL MAY ALSO CAUSE THE SENSOR WINDOW TO CRACK OR LOOSEN. AN ELECTROLYTIC SOLUTION, SUCH AS LYSIS REAGENT (POTENTIALLY REACHING THE SENSOR DUE TO LIQUID WASTE SPLASHING) OR CHLORINE BLEACH (POTENTIALLY USED TO CLEAN THE WASTE BOTTLE OR SENSOR) MAY ENTER THE SENSOR THROUGH A CRACK IN THE COURSE OF THE INSTRUMENT USAGE. ONCE INSIDE, THE ELECTROLYTIC SOLUTION MAY CONTACT THE SENSOR ELECTRONICS CIRCUIT BOARD, CAUSING A SHORT CIRCUIT. THE 8A FUSE DID NOT OPEN IN THE EVENT OF A SHORT SENSOR CIRCUIT TO PREVENT OVERHEATING OF THE SENSOR. THE OVERHEATED SENSOR REACHED IGNITION TEMPERATURE, STARTING A FIRE. RISK EVALUATION ((B)(4)) INDICATES THAT THE HEALTH HARM AND HAZARD DUE TO FIRE CAUSED BY THE MALFUNCTION OF THE LIQUID WASTE SENSOR HAVE SEVERITY LEVEL OF MAJOR AND OCCURRENCE RATE OF RARE. THEREFORE THE RISK LEVEL IS MEDIUM. THE FOLLOWING INTERIM CORRECTIONS HAVE BEEN TAKEN TO MITIGATE THE RISK FOR THE PRODUCT ON MARKET: CUSTOMER LETTERS HAVE BEEN DISTRIBUTED TO ALL M2000SP CUSTOMERS, WHEREIN THE CUSTOMER ARE REQUIRED TO PERFORM VISUAL INSPECTION FOR THE LIQUID WASTE SENSOR IN THE DAILY MAINTENANCE PROCEDURE AND STOP USING THE PRODUCT WHEN CRACKS, DEFORMATION, DISCOLORATION OR OTHER DAMAGES ARE OBSERVED. CUSTOMER ARE ALSO INSTRUCTED TO AVOID USING ALCOHOL OR DETERGENT FOR THE SENSOR CLEANING ((B)(4)). SAME INFO ARE PUBLISHED IN AM INTERNAL COMMUNICATION TECHNICAL BULLETIN ((B)(4)). AM SERVICE PROCEDURE HAS BEEN UPDATED TO AVOID OVERTIGHTENING THE SENSOR MOUNTING SCREWS AND USING ALCOHOL OR DETERGENT FOR THE SENSOR CLEANING. (INTERNAL SERVICE ADVISORY (B)(4)). AM FIELD SERVICE ORGANIZATION KEEPS MONITORING THE LIQUID WASTE SENSOR CONDITIONS IN CUSTOMER SITES AND REPLACE WHEN CRACKS, DEFORMATION, DISCOLORATION OR OTHER DAMAGES ARE OBSERVED. (INTERNAL SERVICE ADVISORY ISA (B)(4)). IN ADDITION, THE FOLLOWING CORRECTIONS ARE MADE TO THE PRODUCTS IN THE INVENTORY AND THE INSTRUMENT MFG PROCESS. WITH THEM IN PLACE, THE MFG AND DISTRIBUTION OF M2000SP CABINETS AND LIQUID WASTE SENSORS ARE RESUMED. TECAN HAS UPDATED THE MFG PROCEDURE TO AVOID OVERTIGHTENING THE SENSOR MOUNTING SCREWS AND USING ALCOHOL OR DETERGENT FOR THE SENSOR CLEANING. (TECAN UPDATED DOCUMENT 392781 ON 10/18/2011). AM PROVIDES EVERY NEW CUSTOMER WITH THE SAME INSTRUCTION AS IN THE CUSTOMER LETTER (B)(4) DURING THE M2000SP INSTRUMENT INSTALLATION (ISA (B)(4)). THE FOLLOWING CORRECTIVE ACTIONS ARE IN PLAN AND WILL BE IMPLEMENTED IN Q1 2012 THROUGH THE DESIGN CHANGE PROCESS. CREATE FORCE-LIMITING PLATE TO BE INSTALLED ON TOP OF THE LIQUID WASTE SENSOR TO FURTHER REDUCE THE LIKELIHOOD OF CRACKING THE SENSOR DUE TO OVER TIGHTENING. CREATE AN ADAPTER CABLE WITH AN IN-LINE FUSE FOR THE LIQUID WASTE SENSOR. THE FUSE IN THE ADAPTER CABLE WILL BE SIZED TO OPEN THE CIRCUIT BEFORE THE SENSOR OVERHEATS IN THE EVENT OF AN ELECTRICAL SHORT IN THE SENSOR. TECAN HAS ALSO RECOMMENDED A PREVENTIVE ACTION BE TAKEN FOR TWO OTHER ELECTRONIC SENSORS LOCATED IN THE M2000SP LOWER CABINET AS A RESULT OF THEIR IMPACT ASSESSMENT. THE FOLLOWING PREVENTIVE ACTION IS IN PLAN AND WILL BE IMPLEMENTED IN Q1 2012 THROUGH THE DESIGN CHANGE PROCESS. CREATE AN ADAPTER CABLE WITH AN IN-LINE FUSE FOR THE SYSTEM FLUID SENSOR AND SOLID WASTE SENSOR. THE FUSE IN THE ADAPTER CABLE WILL BE SIZED TO OPEN THE CIRCUIT BEFORE THE SENSOR OVERHEATS IN THE EVENT OF AN ELECTRICAL SHORT IN THE SENSOR.
THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. DURING INSPECTION OF THE M2000SP LIQUID WASTE SENSOR AT ((B)(4)), THE ABBOTT MOLECULAR GLOBAL SERVICE AND SUPPORT ENGINEER FOUND THAT THE SENSOR HOUSING WAS DISCOLORED. THE SENSOR WAS NOT CRACKED, AND THERE WERE NO SIGNS OF OVERHEATING. ADDITIONALLY, THE SENSOR WAS NOT HOT TO THE TOUCH, AND THE SENSOR HOUSING WAS NOT LOOSE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT M2000SP | JQW | ABBOTT MOLECULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |