MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-29 for VIDAS ANALYZER W2205 manufactured by Biom?rieux Italia.
[24655219]
Evaluated on-site by service engineer.
Patient Sequence No: 1, Text Type: N, H10
[24655220]
A customer in the united states reported a qcv (quality control verification) test failure in association with the vidas system in section b, slot 4. The section was placed offline waiting for the field service engineer to resolve the issue. Samples tested in section b, slot 4 since the last successful qcv (performed (b)(6) 2015, according to the customer) were re-tested, and the customer performed a retrospective analysis. From the last successful qcv until the malfunction reported on (b)(6) 2015, five (5) tests gave a different value on retest: 2 mumps tests initially found negative gave a positive result on retest, 2 lyme tests initially found negative gave a positive result on retest, 1 cmvg test initially found negative gave a positive result on retest. The customer indicated the following initial results were reported to physician: 1 mumps test initially found negative then positive on retest, 2 lyme tests initially found negative then positive on retest, 1 cmvg test initially found negative then positive on retest. There has been no report of death or serious injury as a consequence of "slot b4" test results since the last successful qcv test was performed. There is no indication or report from the hospital or treating physician to biomerieux that the results lead to any adverse event related to the patient's state of health. A biomerieux field service engineer visited the site on (b)(6) 2015 to service the system and resolved the issue. Field service engineer evaluation: 1) performed qcv failure troubleshooting, 2) performed section b pump test - failed, 3) cleaned pump, 4) replaced solid phase receptacle (spr) seals, 5) performed qcv leak test - passed, 6) performed qcv test - passed. Post-service testing indicates system operation is normal. Cause of qcv failure in section b, slot 4 is resolved.
Patient Sequence No: 1, Text Type: D, B5
[40309144]
Biom? Rieux investigation was conducted. Analysis of vidas? Qcv results from the customer : following the observation of low concentration results on the position b04, the customer performed two successive qcv tests on 17jul15. Both qcv tests confirmed a pipetting issue (clogging or leakage) on the position b04. The most recent successful qcv on the position b04 was obtained on 01jul15. The customer follows the biom? Rieux receommendation of perfroming qcv on a monthly basis. The anomaly began sometime after 01jul15. Analysis of the field service engineer (fse) maintenance report for qcv out of range : the fse performed a pump test. The pump test value obtained confirmed a clogged pump channel at the b04 location. The other positions of the section are not affected. The fse cleaned the pump channel. Subsequent pump test conformed to specification. The qcv tests performed after the curative maintenance confirmed that the issue was resolved by the fse intervention. Retrospective analysis : since the last successful qcv on the position b04, five (5) patient tests provided a different value upon retest : 2 mumps tests initially found negative gave a positive result on retest: 2 lyme tests initially found negative gave a positive result on retest; 1 cmvg test initially found negative gave a positive result on retest. Based on details and statements provided by the customer, there is no evidence/indication of any impact on the patient treatment. Following fse intervention, the customer's vidas system is functioning in accordance with specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00059 |
| MDR Report Key | 4949771 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-07-17 |
| Date Mfgr Received | 2015-07-17 |
| Date Added to Maude | 2015-07-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS ANALYZER |
| Generic Name | VIDAS ANALYZER |
| Product Code | DEW |
| Date Received | 2015-07-29 |
| Catalog Number | W2205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX ITALIA |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 PONTE-A EMA FIRENZE, ITALY 50015 IT 50015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-29 |