ARCHITECT REACTION VESSEL
Report
- Report Number
- 1628664-2008-00234
- Event Type
- Malfunction
- Date Received
- October 14, 2008
- Date of Event
- August 15, 2009
- Report Date
- September 30, 2008
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- MMI
- PMA / PMN Number
- K983212
- Removal / Correction Number
- 1415939-2/27/09-003-R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). ARCHITECT (B)(4) ANALYZER LIST#:3M74-02 (B)(4); ARCHITECT STAT TROPONIN-I ASSAY LN: 2K41-01 LOT#: NI. THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME ABBOTT ARCHITECT (B)(4) ANALYZER, IRVING TX MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME ARCHITECT REACTION VESSEL, ABBOTT (B)(4) MANUFACTURING SITE. A COMPLAINT ANALYSIS SHOWED AN INCREASE IN THE FREQUENCY OF COMPLAINTS RELATED TO ERROR CODE 1006, (UNABLE TO PROCESS TEST, BACKGROUND READ FAILURE), ERROR CODE 1007, (UNABLE TO PROCESS TEST, ACTIVATED READ FAILURE), AND INCORRECTLY ELEVATED PATIENT RESULTS. THE READ VALIDITY CHECKS THAT RESULT IN AN ERROR CODE 1006/1007 MONITOR SEVERAL TYPES OF READ ANOMALIES, OF WHICH, ELEVATED RELATIVE LIGHT UNITS (RLU) SPIKES POTENTIALLY DUE TO STATIC DISCHARGE ARE INCLUDED. DETAILED REVIEW OF EACH OCCURRENCE IS NEEDED TO ASCERTAIN THE CAUSE OF THE ERROR. THIS TYPE OF DATA ANALYSIS IS UNDERWAY AS PART OF THE INVESTIGATION. THERE IS NO ANALYTICAL IMPACT FOR THOSE SAMPLES WHERE ERROR CODES 1006, UNABLE TO PROCESS TEST, BACKGROUND READ FAILURE OR 1007, UNABLE TO PROCESS TESTS, ACTIVATED READ FAILURE, OCCURS BECAUSE THE CORRESPONDING TEST GOES TO EXCEPTION AND NO RESULTS ARE REPORTED. FOR THOSE STATIC DISCHARGES THAT OCCUR DURING THE CHEMILUMINESCENT REACTION, THERE IS POTENTIAL FOR FALSELY ELEVATED RESULTS. BASED ON OUR INVESTIGATION TO DATE, REACTION VESSEL (RV) LOTS MADE FROM A PARTICULAR POLYPROPYLENE RESIN LOT ARE A PRIMARY CONTRIBUTOR TO THE INCREASE IN COMPLAINTS. MEASUREMENT OF THE ELECTRICAL CHARGE IMPARTED ON UNUSED RVS SHOWED A STATISTICAL DIFFERENCE BETWEEN AN RV LOT MADE FROM THIS RESIN LOT COMPARED TO RV LOTS MADE FROM DIFFERENT RESIN LOTS. REPLACEMENT RVS USE DIFFERENT RESIN LOTS, BUT STILL COULD EXHIBIT STATIC DISCHARGE AS WE HAVE NOT IDENTIFIED CAUSE. WE ARE IN THE PROCESS OF IDENTIFYING APPROPRIATE MODES OF CONTROL WHILE THE INVESTIGATION PROCEEDS. CORRECTIVE AND/OR PREVENTIVE ACTIONS WILL ALSO BE ADDRESSED THROUGH THE INVESTIGATION. THERE HAVE BEEN NO INJURIES OF MAJOR SEVERITY REPORTED FOR THIS ISSUE FROM ANY ARCHITECT CUSTOMERS. THIS IS AN SUPPLEMENTAL REPORT. AN INVESTIGATION IS STILL IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS
ARCHITECT STAT TROPONIN-I ASSAY LN: 2K41-01 LOT#: UNK. THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE ISSUED AT THE CONCLUSION OF AN INVESTIGATION.
(B)(4). UPON FURTHER REVIEW THE CUSTOMER'S ISSUE IS NOT ASSOCIATED WITH REMEDIAL ACTION REPORTING NUMBER 1415939-02/27/09-003-R. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
(B)(4), ADVERSE EVENT OR PRODUCT PROBLEM:UPON FURTHER REVIEW OF THIS COMPLAINT, THE EVENT DESCRIBED DOES NOT MEET THE DEFINITION OF ADVERSE EVENT, AS THERE WAS NO DEATH OR SERIOUS INJURY REPORTED BY THE COMPLAINANT.CONCOMITANT MEDICAL PRODUCTS:ARCHITECT I2000 ANALYZER, LIST # 3M74-02, (B)(4).EVALUATION: AS NO METHOD, RESULTS OR CONCLUSIONS CAN BE MADE AT THIS TIME.UPON FURTHER REVIEW, THE CUSTOMER ISSUE IS NOW ASSOCIATED WITH REMEDIAL ACTION REPORTING NUMBER 1415939-2/27/09-003-R, AS THE LOT OF THE SUSPECT REACTION VESSEL WAS IN USE AT THE CUSTOMER FACILITY. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
(B)(4). ARCHITECT I2000SR ANALYZER, LIST # 3M74-02, (B)(4). THE INVESTIGATION DETERMINED THE CAUSES OF THE INCREASE IN FREQUENCY OF STATIC DISCHARGE EVENTS WERE DUE TO THE ARCHITECT REACTION VESSELS (RVS) SUPPLIER'S MANUFACTURING MATERIAL AND MANUFACTURING PROCESSES. THE PREVIOUS INVESTIGATION IDENTIFIED RV LOTS MADE FROM A PARTICULAR POLYPROPYLENE RESIN LOT WERE RESPONSIBLE FOR A MAJORITY OF THE STATIC DISCHARGE EVENTS. ANALYSIS OF THIS RESIN LOT DETERMINED IT HAS UNIQUE COMPOSITIONAL AND ANALYTICAL CHARACTERISTICS WHEN COMPARED TO OTHER RESIN LOTS, WHICH FACILITATED THE BUILD-UP OF STATIC CHARGE ON THE RVS. THE PREVIOUS INVESTIGATION ALSO IDENTIFIED VARIABLES WITHIN THE SUPPLIERS' MOLDING MANUFACTURING PROCESS THAT CONTRIBUTED TO STATIC CHARGE VARIATION ACROSS RV LOTS. THE LATEST INVESTIGATION IDENTIFIED ADDITIONAL VARIABLES WITHIN THE SUPPLIERS MOLDING MANUFACTURING PROCESS. ABBOTT HAS IMPLEMENTED MORE STRINGENT STATIC CHARGE SAMPLING AND TESTING FOR ACCEPTANCE OF ALL INCOMING RV LOTS FROM OUR SUPPLIER. ABBOTT HAS WORKED IN CLOSE COLLABORATION WITH OUR SUPPLIERS TO ASSURE CONSISTENCY OF INCOMING RESIN MATERIAL, AND TO IMPROVE THE SUPPLIER'S MOLDING PROCESS TO REDUCE THE POTENTIAL GENERATION OF STATIC CHARGE.
(B)(4). ARCHITECT I2000SR ANALYZER LIST#:3M74-02 (B)(4). ARCHITECT STAT TROPONIN-I ASSAY LN: 2K41-01 LOT#: NI. THE INVESTIGATION DETERMINED THE CAUSES OF THE INCREASE IN FREQUENCY OF STATIC DISCHARGE EVENTS WERE DUE TO THE ARCHITECT REACTION VESSELS (RVS) SUPPLIER'S MANUFACTURING MATERIAL AND MANUFACTURING PROCESSES. THE INVESTIGATION IDENTIFIED VARIABLES WITHIN THE SUPPLIERS' MOLDING MANUFACTURING PROCESS THAT CONTRIBUTED TO STATIC CHARGE VARIATION ACROSS RV LOTS. OTHER CONTRIBUTING FACTORS THAT CAN GENERATE A STATIC CHARGE ON THE RVS INCLUDE LOW HUMIDITY, HANDLING, SHIPPING AND CREATION OF CHARGE WITHIN THE ARCHITECT INSTRUMENTS THEMSELVES. IN ADDITION, ABBOTT HAS IMPLEMENTED STATIC CHARGE TESTING FOR ACCEPTANCE OF ALL INCOMING RV LOTS FROM OUR SUPPLIER. ABBOTT HAS WORKED IN CLOSE COLLABORATION WITH OUR SUPPLIERS TO ASSURE CONSISTENCY OF INCOMING RESIN MATERIAL, AND TO IMPROVE THE SUPPLIER'S MOLDING PROCESS TO REDUCE THE POTENTIAL GENERATION OF STATIC CHARGE. A REVIEW OF THE ARCHITECT SYSTEM OPERATIONS MANUAL FOUND SUFFICIENT INFORMATION ON HOW TO RECOVER FROM ERROR CODES ASSOCIATED WITH THIS ISSUE. END OF REPORT.
(B)(4). THIS COMPLAINT IS NOW ASSOCIATED WITH CORRECTION AND REMOVAL NUMBER 1415939-2/27/09-003-R. THE INITIAL MDR WAS FILED AGAINST THE ARCHITECT I2000SR ANALYZER, LIST NUMBER 3M74-02, MANUFACTURING SITE, (B)(4). UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE CAUSATIVE AGENT FOR THIS ISSUE IS THE ARCHITECT REACTION VESSELS. AN INVESTIGATION IS STILL IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
THE CUSTOMER STATES THAT ONE PATIENT GENERATED AN INITIAL ARCHITECT STAT TROPONIN-I ASSAY RESULT OF 0.134 NG/ML. THE RESULT WAS REPORTED AND QUESTIONED BY THE PATIENT'S PHYSICIAN AS THERE WAS NO CLINICAL EVIDENCE OF A HEART ATTACK. THE SAMPLE RETESTED AT 0.04 NG/ML. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION BASED ON THE INITIAL RESULT WITH NO EVIDENCE OF SERIOUS INJURY OR INTERVENTION TO PREVENT SERIOUS INJURY. IN TOTAL, TEN PATIENT SAMPLES GENERATED ELEVATED TROPONIN-I RESULTS THAT RETESTED AT LOWER VALUES. IN NO CASE WAS ANY INVASIVE TREATMENT PERFORMED ON ANY OF THE PATIENTS. THE CUSTOMER ONLY PROVIDED THE RESULTS OF ONE PATIENT'S HOSPITALIZATION AS AN EXAMPLE. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.
IT WAS REPORTED THAT THE PT EXPERIENCED INCREASE IN SPASTICITY OF THE LOWER EXTREMITIES. CONTRAST STUDY FINDINGS: UNABLE TO ASPIRATE CEREBROSPINAL FLUID FROM THE PUMP RESERVOIR AND CONTRAST DID NOT FLOW INTO THE THECAL SAC. THIS WAS CONSISTENT WITH A 'PUMP MALFUNCTION WHICH WAS CAUSING THE RECURRENT SYMPTOMS'. THE PT WAS ADMITTED IN 2009 FOR PUMP REPLACEMENT. INTRAOPERATIVE FINDINGS: THERE WAS A BREAK IN THE CATHETER PROXIMAL TO THE ANCHOR AND THE CATHETER WAS REMOVED. THE FASCIA WAS OPENED TO IDENTIFY THE REMAINDER OF THE CATHETER BUT IT WAS NOT EASILY FOUND. IT WAS DECIDED TO LEAVE THE OLD CATHETER IN PLACE AND IMPLANT A NEW CATHETER. THERE WERE NO OPERATIVE COMPLICATION; THE PT TOLERATED THE PROCEDURE WELL. ADDITIONAL INFO FROM THE USER FACILITY: PT WITH HISTORY OF MULTIPLE SCLEROSIS, AND LOWER EXTREMITY SPASTICITY UNDERWENT PLACEMENT OF AN INTRATHECAL (BACLOFEN) PUMP SEVEN MONTHS PRIOR TO REPLACEMENT. RECENT INCREASE IN SPASTICITY OF THE LOWER EXTREMITIES. STUDY FINDINGS: INABILITY TO ASPIRATE CEREBROSPINAL FLUID FROM THE PUMP RESERVOIR AND CONTRAST DID NOT FLOW INTO THE THECAL SAC. FINDINGS WERE CONSISTENT WITH A PUMP MALFUNCTION WHICH WAS CAUSING THE RECURRENT SYMPTOMS. PT ADMITTED ON EVENT DATE FOR PUMP REPLACEMENT. INTRAOPERATIVE FINDINGS: BREAKAGE IN CATHETER PROXIMAL TO THE ANCHOR AND THE CATHETER WAS REMOVED. THE FASCIA WAS OPENED TO IDENTIFY THE REMAINDER OF THE CATHETER BUT IT WAS NOT EASILY FOUND. IT WAS DECIDED TO LEAVE THE OLD CATHETER IN PLACE AND PLACE A NEW CATHETER. NO OPERATIVE COMPLICATIONS AND THE PT TOLERATED THE PROCEDURE WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT REACTION VESSEL | REACTION VESSELS FOR CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAYS | MMI | ABBOTT LABORATORIES | NA | 62616P100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization | ARC REACTION VESSEL LN: 7C15-02 LOT#: 62616P100 |