VIDAS® ESTRADIOL II
Report
- Report Number
- 3002769706-2018-00214
- Event Type
- Malfunction
- Date Received
- October 12, 2018
- Report Date
- May 27, 2019
- Manufacturer
- BIOMERIEUX SA
- Product Code
- CHP
- PMA / PMN Number
- K955647
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IV
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: DATE OF THIS REPORT, WAS CORRECTED FROM 05/29/2019 TO 05/27/2019.
AN INTERNAL INVESTIGATION WAS PERFORMED FOR FALSELY ELEVATED RESULTS WITH THE VIDAS® ESTRADIOL (E2II) ASSAY (REF 30431) WHEN COMPARED TO TWO OUTSOURCE LABS USING OTHER METHODS AND THE PATIENT EXAMINATION. THE VIDAS E2II RESULTS WERE HIGHER WHEN COMPARED WITH OTHER METHODS FOR TWO LOTS VIDAS E2 II LOT 1006354130 /190227-0 AND LOT 1006156500/ 181128-0. REVIEW OF QUALITY CONTROL RECORDS: ONE OTHER SIMILAR COMPLAINT RECORDED FOR THE SAME ISSUE ON THE BATCH 1006354130/190227-0. THE BATCH HISTORY RECORDS SHOW NO ANOMALY RECORDED DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. NO CAPA NOR NON-CONFORMITY RECORDED LINKED TO THE CUSTOMER'S COMPLAINT RECORDED ON VIDAS E2 II LOT 1006354130. A STUDY OF THE QUALITY CONTROL CHARTS WAS PERFORMED FOR FIVE INTERNAL SERA ON EIGHT LOTS OF VIDAS E2II (INCLUDING CUSTOMER'S LOTS) AND ALL THE RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER'S LOTS ARE IN THE TREND OF THE OTHER LOTS. TESTING: FOUR INTERNAL SERA WERE TESTED ON TWO VIDAS E2 II LOTS (1006354130 /190227-0 AND LOT 1006156500/ 181128-0). ALL THE RESULTS WERE WITHIN EXPECTED SPECIFICATION , WITH NO EVOLUTION SINCE BATCH RELEASE. FOUR FRESH SERA FROM BLOOD DONOR WERE TESTED ON THREE VIDAS E2 II LOTS (181128-0 , 190227-0 AND LOT 190918-0) WITH DIFFERENT RAW MATERIAL. THESE SERA WERE SENT TO AN EXTERNAL LABORATORY IN ORDER TO TEST THE RIA (RADIO IMMUNO ASSAY) METHOD. THE RESULTS OBTAINED SHOWED A HIGHER RESULT WITH VIDAS E2 II ON THE TOP OF THE CURVE COMPARED TO RIA METHOD. THE CUSTOMER'S ANOMALY WAS REPRODUCED SO A COMPLETE ANALYSIS OF EXTERNAL QUALITY CONTROL RESULTS (LYPHOCHEK BIORAD) WAS PERFORMED. THE DATA WERE COLLECTED FROM EXTERNAL QUALITY CONTROLS WHICH ARE NOT CONSIDERED AS PATIENTS SAMPLES BUT AS TOOLS WHICH PERMIT TO SEE IF THERE IS OR NOT DRIFT ON THE METHODS. IN SIX YEARS THE STUDY OF PROBIOQUAL DATA SHOWS NO DEVIATION ON VIDAS E2II PARAMETER. IN PARALLEL AN ADDITIONAL STUDY WAS PERFORMED ON ONE LOT OF LYPHOCHEK , TO COMPARE RESULTS BETWEEN VIDAS E2II AND TEN (10) OTHER COMPETITOR'S METHODS. DATA SUPPLIED BY BIORAD AND ANALYZED SHOWN THAT VIDAS RESULTS ARE NOT HIGHER THAN THE COMPETITORS' RESULTS. SOME COMPETITOR METHODS GAVE HIGHER RESULTS THAN VIDAS E2II AND SOME OTHER GAVE LOWER RESULTS THAN VIDAS E2II THE VIDAS® ESTRADIOL II ASSAY IS CALIBRATED AGAINST THE ID-GCMS (ISOTOPE DILUTION - GAS CHROMATOGRAPHY MASS SPECTROMETRY) TECHNIQUE. IT IS NOTED THAT HORMONES ARE PARTICULARLY DIFFICULT TO TEST, THAT'S WHY IT IS VERY IMPORTANT TO PAY ATTENTION TO THE PRE-ANALYTICAL PHASE FOR THEIR TESTING. MOREOVER, THERE IS NO PERFECT CORRELATION BETWEEN THE DIFFERENT COMPETITORS. PACKAGE INSERT REMINDER CONCERNING "RANGE OF EXPECTED VALUES": "THESE FIGURES ARE GIVEN AS A GUIDE. IT IS RECOMMENDED THAT EACH LABORATORY ESTABLISHES ITS OWN REFERENCE VALUES FROM A RIGOROUSLY SELECTED POPULATION." CONCLUSION : THERE IS NO DEVIATION OBSERVED INTERNALLY OF THE REAGENT VIDAS E2II REF 30431 SINCE 2015. CONTROL DATA OF INTERNAL SAMPLES AND EXTERNAL QUALITY CONTROLS DIDN'T SHOW ANY DIFFERENT BEHAVIOR COMPARED WITH OTHER LOTS STUDIED. THE LOT CONCERNED BY THE ISSUE IS IN THE TREND OF THE OTHER LOTS. DATA SUPPLIED BY BIORAD AND ANALYZED SHOWN THAT VIDAS RESULTS ARE NOT HIGHER THAN THE COMPETITORS' RESULTS. ACCORDING TO THE INFORMATION/DATA MENTIONED ABOVE THE REAGENT VIDAS E2 II LOT 190219-0 IS CONFORM TO THEIR EXPECTED SPECIFICATIONS. PACKAGE INSERT REMINDERS : "RESULTS AND INTERPRETATION" EXTRACTS: "THE VIDAS® ESTRADIOL II ASSAY IS CALIBRATED AGAINST THE ID-GCMS (ISOTOPE DILUTION - GAS CHROMATOGRAPHY MASS SPECTROMETRY) TECHNIQUE." "ANY CONCENTRATION VALUES OF ESTRADIOL OBTAINED SHOULD BE USED FOR DIAGNOSIS IN ASSOCIATION WITH ADDITIONAL INFORMATION GATHERED BY THE PHYSICIAN (PATIENT QUESTIONING, CURRENT DRUG THERAPY, ULTRASOUND SCAN, CLINICAL OBSERVATIONS, OTHER EXAMINATIONS, ETC.). IN CASES OF ESTROGEN THERAPY, AND PARTICULARLY THAT OF HORMONE REPLACEMENT THERAPY (MENOPAUSE), OVERESTIMATED RESULTS MAY BE OBTAINED. INTERPRETATION OF TEST RESULTS SHOULD BE MADE TAKING INTO CONSIDERATION THE PATIENT'S HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED."
A CUSTOMER FROM THE (B)(6) NOTIFIED BIOMÉRIEUX OF POTENTIAL FALSELY ELEVATED RESULTS WHEN TESTING WITH THE VIDAS® ESTRADIOL ASSAY ((B)(4)). THE CUSTOMER PROVIDED THE FOLLOWING RESULTS AS COMPARED TO TWO OUTSOURCE LABS THAT ALSO TESTED THE RESULTS: VIDAS RESULT, OUTSOURCE RESULT 1, OUTSOURCE RESULT 2. (B)(4). THE CUSTOMER STATED THAT THE OUTSOURCED RESULT APPEARS LOWER THAN THEIR RESULT. WHEN COMPARED TO THE SCAN RESULTS THE DOCTORS USUALLY GET ON THEIR PATIENTS, THE OUTSOURCED LAB RESULTS WERE MORE IN LINE WITH THE SCANS THAN THE CUSTOMER'S VIDAS RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING PATIENT RESULTS SPECIFIC TO THIS LOT: ON LOT NUMBER 1006156500, TWO PATIENTS: ONE CONFORM CALIBRATION ON (B)(6) 2018. TWO PATIENT RESULTS: 134.51 PMOL/L, 142.80 PMOL/L. ONE CONFORM CALIBRATION ON (B)(6) 2018. TWO PATIENT RESULTS: 93.55 PMOL/L, 78.76 PMOL/L. THE CUSTOMER REPORTED THAT PATIENT RESULTS WERE AFFECTED, AND WRONG RESULTS WERE REPORTED TO THE PHYSICIAN. HOWEVER, THE PHYSICIAN DID NOT AGREE WITH THE RESULT AND DID NOT USE IT. NO INCORRECT TREATMENT WAS PROVIDED AND THERE WAS NO PATIENT HARM. THE CUSTOMER ALSO REPORTED THAT THERE WAS NO DELAY IN REPORTING RESULTS DUE TO THE DISCREPANT RESULT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 800260 | VIDAS® ESTRADIOL II | VIDAS® ESTRADIOL II | CHP | BIOMERIEUX SA | 1006156500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |