CD3200SL 110
Report
- Report Number
- 2919069-2008-00427
- Event Type
- Death
- Date Received
- March 4, 2008
- Date of Event
- February 4, 2008
- Report Date
- February 14, 2008
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION/CELLDYN
- Product Code
- GKZ
- PMA / PMN Number
- K972354
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DR
- Reporter Occupation
- OTHER
Narratives
PRELIMINARY INVESTIGATION SUMMARY: NOTE: INVESTIGATION STILL PENDING AT THIS TIME (2/27/2008). HOWEVER, REVIEW OF THE AVAILABLE CUSTOMER INFO, LABELING AND TRACKING AND TRENDING INFO HAS FOUND THE FOLLOWING: ON APPROX TWO WEEKS EARLIER, THE CUSTOMER AT THE HOSP REPORTED AN ISSUE WITH PLATELET (PLT) RESULTS FROM A CELL-DYN 3200SL. THE PT HAD LEUKEMIA AND DIED A FEW DAYS LATER. BOTH COMPLAINT TEXT AND FAXED INFO WAS REVIEWED. THE TECHNICAL SERVICE SPECIALIST (TSS) CONTACTED THE MEDICAL DIRECTOR AT THE CLINIC FOR ADDITIONAL INFO ON THE PT, HOWEVER, THE DOCTOR WAS UNABLE TO DISCLOSE PT INFO OVER THE PHONE BECAUSE OF LAWS. A FIELD SERVICE REP (FSR) WAS SENT OUT TO VERIFY THE INSTRUMENT PERFORMANCE. REQUEST WAS MADE 2/14, FSRS WERE INFORMED 2/15/08 AND THE VISIT WAS MADE 2/18/08 (PER SERVICE ORDER INFO) . REVIEW OF THE PRE- INVESTIGATION: THERE HAD BEEN A PROBLEM WITH PLT BACKGROUNDS OUT OF RANGE SINCE THE MONTH BEFORE. THE CONTROLS HAD TO BE RUN SEVERAL TIMES (4 OR MORE) TO FALL IN RANGE BUT AT THE LIMITS. THE CUSTOMER REPORTED THAT THE LABORATORY TEMPERATURE HAD BEEN WARM THE PAST MONTH (AIR CONDITIONING ISSUE). A REPORT FROM HOSP, DATED FEB 11, STATED IT TESTED A REFRIGERATED SAMPLE FROM A WEEK BEFORE. THE SAMPLE WAS SENT OUT TO THE HOSP ON FEB 11TH AND RECEIVED BY THE HOSP ON FEB 12TH. FIVE PT RESULTS (INSTRUMENT PRINTOUTS) RESULTS FOR PATIENT WERE AS FOLLOWS (NO SIMILAR PT ID ON RESULTS): A REVIEW OF THE DATA SHOWED THAT NUMEROUS FLAGS WERE GENERATED BY THE CD 3200 ANALYZER TO ALERT THE OPERATOR OF SUSPECT RESULTS. A REVIEW OF CONTROL LOGS INDICATED THAT THE CUSTOMER WAS HAVING ISSUES WITH GETTING CONTROLS IN ACCEPTABLE RANGE AND THAT CONTROLS WERE OUT OF RANGE FOR MULTIPLE PARAMETERS REPEATEDLY. A REVIEW OF BACKGROUND LOGS INDICATED THAT PLATELET BACKGROUNDS WERE OUT OF RANGE ON MULTIPLE OCCASIONS. REVIEW OF THE OPERATOR MANUAL (06H60-01, REV M) BACKGROUNDS: PLATELET BACKGROUND SHOULD BE =<5K/UL (P. 4-9). PAGE 5-97 STATES UNDER ALERTS AND INDICATORS THE RESULTS THAT EXCEED A PARAMETER'S LINEARITY ARE INDICATED BY >>>> IN PLACE OF THE RESULT. WHEN THE INSTRUMENT IS STARTED (P. 5-63, 5-87, 5-93) BACKGROUNDS SHOULD BE RUN. IF BACKGROUNDS ARE NOT IN RANGE, THE BACKGROUNDS SHOULD BE REPEATED UNTIL THEY ARE IN RANGE OR TROUBLESHOOTING COMPLETED. CONTROLS SHOULD BE RUN AFTER COMPLETION OF THE DAILY START-UP BACKGROUNDS. (5-63, 11-17) THE SECTION OF TROUBLESHOOTING BACKGROUND ISSUES (P. 10-25) REFERS THE READER TO TABLE 10.4 (NON-FUNCTIONAL FAULT CONDITIONS). PAGE 10-89 HAS A LIST OF 6 PROBABLE CAUSES WITH CORRECTIVE ACTIONS. THE CORRECTIVE ACTIONS MENTIONED IN THE COMPLAINT TEXT WERE DILUENT/SHEATH FILTER (#4), SYRINGES ( #5). SAMPLE STABILITY: RESULTS ARE RELIABLE FOR RBC, HGB, MCV, PLT UP TO 36 HOURS IF REFRIGERATED AT TEMPERATURES OF 2 TO 8OC - ALTHOUGH WBC AND MPV RESULTS ARE STABLE UP TO 24 HOURS. TOTAL WBC MAY DECREASED +/-10% AT 36 HOURS. (P. 5-83). THEREFORE, THE RUNS MADE 6 DAYS LATER ON THE SAMPLE WOULD NOT HAVE RELIABLE RESULTS. FLAGGING: THE ORIGINAL RESULT SHOULD HAVE HAD FURTHER ACTIONS TAKEN. THERE WERE DISPERSIONAL DATA ALERTS SUSPECT PARAMETER FLAGS, SUSPECT POPULATION FLAGS AND INTERPRETIVE MESSAGES PRESENT ON THE FIRST AND SECOND RUNS OF THIS SAMPLE DISPERSIONAL DATA ALERTS WERE PRESENT AND THE RECOMMENDED RESPONSE IS TO REPEAT THE SAMPLE, NOTIFY A PHYSICIAN OR REVIEW A SMEAR (P. 3-31). THE SAMPLE WAS REPEATED AND THE FLAGGING WAS DUPLICATED. TABLE 3.4 (PAGES 3-33 TO 3-35) PROVIDE SUGGESTED ACTIONS FOR THE FLAGGING SEEN (WBC, VAR LYM, NRCB/RRBC, DFLT (NLMES), RBC MORPH). SUGGESTED ACTIONS INCLUDE: REPEATING THE SAMPLE IN DIFFERENT MODES (RESISTANT RBC MODE FOR WBC NRBC/RRBC; FWBC MODE FOR DFLT (NLMEB)]; REVIEWING A SMEAR [DFLT (NLMEB), RBC MORPH]; REVIEWING SCATTER GRAMS [NRBC, DFLT (MLMEB), RBC MORPH]; VERIFYING WBC BY ALTERNATIVE METHOD [WBC NRBC/RRBC]. IF THE MPV DATA IS SUPPRESSED, REVIEW THE SMEAR FOR ABNORMAL PLATELET MORPHOLOGY AND PLATELET AGGREGATES AND FOLLOW YOUR LABORATORY'S REVIEW CRITERIA. VERIFY THE PLATELET COUNT. (P. 3-35). INTERFERING SUBSTANCES: THIS WAS A PT WITH LEUKEMIA (TYPE UNKNOWN) THE PLT PARAMETER MAY BE AFFECTED BY WBC FRAGMENTS. (P.3-28) TRENDING INFORMATION: A REVIEW OF COMPLAINT REPORTS, FOR THE PERIOD OF JUNE 2007 THROUGH JANUARY 2008, DID NOT INDICATE ANY ADVERSE TREND FOR CELL-DYN 3200, LIST BASE 04H60-01 FOR THE COMPLAINT ISSUE. THE EVENT IS ADDRESSED IN THE CELL-DYN 3200 SYSTEM OPERATOR'S MANUAL, 06H60-01, REV M SECTION 3 PRINCIPLES OF OPERATION: OPERATIONAL MESSAGES AND DATA FLAGGING: CELL POPULATIONS AND FLAGGING: 3-28 TO 3-31. DATA FLAGGING: TABLE 3.4 SPECIMEN TYPES: 3-33 TO 3-35 SECTION 4: PERFORMANCE CHARACTERISTICS AND SPECS: OPERATIONAL SPECS: RUN CYCLE TIMES; P. 4-5 PERFORMANCE SPECS: BACKGROUND COUNTS; 4-9 SECTION 5: OPERATING INSTRUCTIONS: SAMPLE ANALYSIS ON THE CELL-DYN 3200SL: START-UP PROCEDURES; 5-63 INTRODUCTION: 5-87 SAMPLE COLLECTION AND HANDLING: SAMPLE STABILITY 5-83 ALERTS AND INDICATORS: 5-97 DATA LOG CODES: 5-137 SECTION 10" TROUBLESHOOTING AND DIAGNOSTICS: TROUBLESHOOTING PROCEDURES: TROUBLESHOOTING THE BACKGROUND COUNT 10-25, 10-26 TABLE 10.4 NON-FUNCTIONAL FAULT CONDITIONS (CONTINUED) BACKGROUND COUNT IS OUTSIDE ACCEPTABLE LIMITS: 10-89 SECTION 11: QUALITY CONTROLS: RUNNING CONTROLS: 11-17. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. END OF REPORT.
THE CUSTOMER STATES THAT A PLATELET RESULT GENERATED FOR ONE PT SAMPLE USING A CELL-DYN 3200 SL ANALYZER DID NOT AGREE WITH A RESULT GENERATED BY ANOTHER ANALYZER FOR THE SAME SAMPLE STORED REFRIGERATED AND TESTED SEVERAL DAYS LATER. A SAMPLE FROM A LEUKEMIA PT WAS TESTED IN 2008 AND THE CELL-DYN 3200 ANALYZER GENERATED A PLT=669 K/UL, WBC=15.8 K/UL, HGB=6.05 G/DL. THE PT RECEIVED A BLOOD TRANSFUSION AS PART OF TREATMENT. THE PT EXPIRED A FEW DAYS LATER (DATE OF DEATH AND CAUSE OF DEATH NOT PROVIDED). SUBSEQUENT TESTING: 2008: PLT=463 K/UL, WBC=15.1 K/UL, HGB=6.27 G/DL. ON A WEEK LATER: PLT=186 K/UL, WBC=10.3 K/UL, HGB=6.37 G/DL (ORIGINAL DATE, SAMPLE) RUN ON CELL-DYN 3200 ANALYZER. ON THE NEXT DAY: PLT=25 K/UL, WBC=21.5 K/UL, HGB=5.92 G/DL (ORIGINAL DATE, SAMPLE) CD3500 ANALYZER RUN AT ANOTHER FACILITY. INVESTIGATION PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD3200SL 110 | AUTOMATED HEMATOLOGY ANALYZER | GKZ | ABBOTT DIAGNOSTICS DIVISION/CELLDYN | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death |