MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-06-20 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[47794213]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[47794214]
A customer in (b)(6) contacted biomerieux to report a sampling issue (error 0522) for all vidas 3 instrument sections while performing a lyme igg assay. Other assays function as intended. Error 0522 is an alarm for which the goal is to prevent the potential reporting of an inaccurate result due to pumping issues. The error typically occurs when a smart pump is not functioning properly and needs to be replaced. In most cases, the assay would be performed in a different section, as was attempted by the customer for this occurrence. However, all sections failed with error 0522 for the lyme igg test. Error 0522 does not have an impact on the accuracy of reported results; however, the customer reported a four-day delay to report lyme igg assay results. There is no indication or report from the laboratory that the vidas 3 error 0522 condition associated with the lyme igg assay led to any adverse event related to any patient's state of health. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[61251411]
A customer in france contacted biom? Rieux to report a sampling issue (error 0522) for all vidas 3 instrument sections while performing a lyme igg assay. An internal biom? Rieux investigation was performed. Results are as follows: a customer reported an error 0522 on vidas lyme igg batch 1004673730 / 170124-0. The analysis of the batch history records lot 1004673730 / 170124-0 shows no anomaly during the control process except the use of the "coating chamber". -testing included 15 sprs from each pouch on the in-house kit vidas lyme igg lot 1004673730 / 170124-0 and 12 sprs from each pouch on the return kit vidas? , so in total, 54 sprs were tested. The % of the error 0522 is: -1 error found for 30 strips and sprs tested so 3 % of errors with the retain kit lot 1004673730 / 170124-0. -1 error found for 24 strips and sprs tested so 4 % of errors with the return kit lot 1004673730 / 170124-0. One error 0522 was reproduced on the return kit and another on the retained kit; therefore, the recurrence was determined to be 3. 7%. The update of the coating chamber to the 4th generation is needed to avoid such issue in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00110 |
| MDR Report Key | 5736703 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-20 |
| Date of Report | 2016-05-27 |
| Date Mfgr Received | 2016-05-27 |
| Device Manufacturer Date | 2016-02-19 |
| Date Added to Maude | 2016-06-20 |
| 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. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? LYME IGG |
| Generic Name | VIDAS? LYME IGG |
| Product Code | LSR |
| Date Received | 2016-06-20 |
| Catalog Number | 30320 |
| Lot Number | 1004673730 |
| Device Expiration Date | 2017-01-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-20 |