VIDAS® ESTRADIOL II
Report
- Report Number
- 8020790-2021-00190
- Event Type
- Malfunction
- Date Received
- September 16, 2021
- Report Date
- November 6, 2021
- Manufacturer
- BIOMERIEUX SA
- Product Code
- CHP
- PMA / PMN Number
- K955647
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED OUT OF RANGE (TOO LOW) RESULTS FOR THE EQC SAMPLE HM 3/21 A FROM RFB WITH VIDAS® ESTRADIOL II (REF. (B)(4)/ LOT# 1008504390). CUSTOMER RESULTS: 37.9 PG / ML. EXPECTED RESULT: 62.5 (40.3 - 84.5) PG / M. INVESTIGATION: THE COMPLAINT ANALYSIS FOUND THAT NO OTHER COMPLAINTS FOR SIMILAR ISSUES HAVE BEEN REPORTED ON THIS BATCH. THERE ARE NO CAPAS NOR NON-CONFORMITIES LINKED WITH CUSTOMER 'S COMPLAINT. THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT HIGHLIGHT ANY ISSUES DURING MANUFACTURING FOR VIDAS® ESTRADIOL II (REF. (B)(4)/LOT# 1008504390). CONTROL CHART ANALYSIS: CONTROL CHART ANALYSIS WAS CARRIED OUT ON 4 INTERNAL SAMPLES WITH TARGETS BETWEEN 24.6 AND 219 PG / ML, USING 7 BATCHES OF VIDAS ESTRADIOL II INCLUDING THE BATCH MENTIONED BY THE CUSTOMER (1008504390). ALL RESULTS WERE WITHIN SPECIFICATIONS AND THE RESULTS FROM THE CUSTOMER¿S LOT ARE CONSISTENT WITH THE OTHER LOTS. RETAIN SAMPLE TESTING THE COMPLAINTS LABORATORY TESTED FOUR INTERNAL SAMPLES ON RETAIN KITS FROM VIDAS® ESTRADIOL II LOT 1008504390. THE RESULTS OBTAINED WERE WITHIN ACCEPTABLE RANGE AND ARE SIMILAR TO THOSE OBTAINED AT THE RELEASE OF THE BATCH. THERE IS NO EVIDENCE OF THE RESULTS DRIFTING SINCE RELEASE OF THE LOT. CUSTOMER SAMPLE TESTING: THE COMPLAINT LABORATORY TESTED THE RFB SAMPLE A AND B RETURNED BY CUSTOMER. THE RESULTS OBTAINED ON RFB SAMPLES A AND B HM3 / 21 ARE COMPLIANT TO THEIR RANGE. CONCLUSION: THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE CUSTOMER'S ANOMALY FOR VIDAS ESTRADIOL II UNDER ESTIMATED RESULTS. IT IS IMPORTANT TO NOTE THAT THE INTERNAL CONTROL RESULTS ARE LINKED TO PRE ANALYTIC STEP FOR RECONSTITUTION OF THE LYOPHILIZED VIALS (DILUENT, VOLUME, WAITING TIME, MIXING). MOREOVER, IT IS MENTIONED IN THE CLSI GUIDELINE EP14-A3 THAT PROCESSED SAMPLES USED AS QC MATERIAL (EG EQA) CAN HAVE MATRIX EFFECT: ¿CURRENT SCIENTIFIC DATA SUGGEST THAT SUCH USE OF PT / EQA RESULTS IS NOT ALWAYS FEASIBLE BECAUSE OF MATRIX EFFECTS. THESE PROCESSED MATERIALS US AS PT / EQA SAMPLES SOMETIMES DO NOT BEHAVE LIKE PATIENT SAMPLES ROUTINELY ANALYZED IN THE LABORATORY. BIASES NOT GENERALLY SEEN WITH FRESH BIOLOGICAL FLUIDS, ARE FREQUENTLY SEEN WITH PT / EQA SAMPLES ¿ ACCORDING TO THE ABOVE DATA, THE KIT VIDAS ESTRADIOL II BATCH (LOT 1008504390) IS WITHIN THE EXPECTED PERFORMANCES.
ON (B)(6) 2021, A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF UNDERESTIMATED RESULTS WHEN TESTING WITH VIDAS® ESTRADIOL II (E2II) (REFERENCE #: 30431), (LOT NUMBER:1008504390, EXPIRY DATE: 04JAN2022) IN CONTEXT OF EXTERNAL QUALITY CONTROL (QC). EXTERNAL QC, RFB, HM3/21, SAMPLE A: 37.9 PG/ML. EXPECTED RESULT: 62.5 (40.3 - 84.5) PG/ML. THE CUSTOMER FAILED THEIR EXTERNAL QC AND DID NOT RECEIVE THE CERTIFICATE FOR THIRD QUARTER. THERE IS NO PATIENT ASSOCIATED WITH THIS EXTERNAL QC SAMPLE; THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE 30431 IS NOT REGISTERED IN THE UNITED STATES. THE U.S SIMILAR DEVICE IS PRODUCT REFERENCE 30431-01 (K955647).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1377393 | VIDAS® ESTRADIOL II | VIDAS® ESTRADIOL II | CHP | BIOMERIEUX SA | 1008504390 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |