MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-06-02 for VIDAS? ANALYZER 99735 manufactured by Biomerieux, S.a..
[46472204]
A customer in (b)(6) notified biom? Rieux of discrepant quality control results associated with the vidas? Analyzer. The customer reported a very low value vt1 of 1. 06 instead of 5. 6 for position d1 during the quality control process. Retrospective analysis was performed on the position d1 for the period of time dec2015 to 02may2016 and 13 samples were re-checked. The customer indicated for one (1) patient the cytomegalovirus (cmv) igm was negative initially, but changed to positive after retesting; however, according to the customer, there was no patient impact as the patient was not pregnant and the cmv igg was positive as well. An internal biom? Rieux investigation will be initiated
Patient Sequence No: 1, Text Type: D, B5
[55240174]
A customer in (b)(6) contacted biom? Rieux to report a qcv (quality control verification) failure (position d1) in association with the vidas? Analyzer. The customer reported a low value (vt1) of 1. 06 instead of >5. 6 for position d1 during the qcv process. Biom? Rieux internal and on-site investigations were performed. The last successful qcv was performed 07-mar-2016. Note: the instructions for use (package insert reference (b)(4)) indicate qcv must be performed by the customer at least once per month in each position of the vidas? Analyzer or anytime that a pipetting problem is suspected. As requested by biom? Rieux, the customer stopped using section d of the vidas? Analyzer and performed a retrospective analysis between the last successful qcv (07-mar-2016) and the failed qcv (02-may-2016). After the customer reported the problem of qcv failure, the local biom? Rieux field service engineer (fse) visited the customer site to perform local evaluation of the issue. The fse confirmed the problem in position d1 by performing a new qcv where the result of tv1 for the position d1 was 1. 07 instead of >5. 6. The fse resolved the failure by replacing the position d1 pump; resolution was confirmed via qcv and pump tester. The retrospective analysis showed that no risk on patient following a false interpretation has been detected:? For 12 of them, there was no change of interpretation during a new performed test : - 5 results were positive and stayed positive after performing a new test - 7 results were negative and stayed negative after performing a new test? For 1 of them, there was no need to perform a new test as the interpretation was consistent with an old infection? For 1 of them, there was change of interpretation during a new performed test: - result was negative and became positive after performing a new test but there was no impact according to the customer as it concerned a cmvm test on a female patient who was not pregnant and as a cmvg test on the same patient was also positive. There is no indication or report from the laboratory that the failed qcv and subsequent retrospective analysis identified any adverse event related to any patient's state of health. Observation of a qcv failure is not abnormal behavior or a malfunction. A qcv failure indicates the qcv test played its role as a functional control. This control is meant to detect residual risks. The customer reacted appropriately and the failing instrument section was placed off-line until repair could be made.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00097 |
| MDR Report Key | 5695893 |
| Report Source | FOREIGN |
| Date Received | 2016-06-02 |
| Date of Report | 2016-05-02 |
| Date Mfgr Received | 2016-05-24 |
| Date Added to Maude | 2016-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? ANALYZER |
| Generic Name | VIDAS? ANALYZER |
| Product Code | OMI |
| Date Received | 2016-06-02 |
| Catalog Number | 99735 |
| Lot Number | DASA4805 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, S.A. |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-02 |