MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for VIDAS? MEASLES IGG 30219 manufactured by Biomerieux Sa.
[117865723]
Batch history records were reviewed, with no anomaly noted during the manufacturing, control and packaging processes. Control charts analysis: the complaint laboratory observed five internal samples (target tv: 0. 75-0. 79-0. 99-0. 91-0. 16) on five different batches. The analysis of the control charts on the five internal samples showed that all vidas msg lot 1005989450 / 180726-0 is in the trend of the parameter. Test performed by complaint laboratory: the complaint laboratory tested five internal samples (same samples as control charts, see above) with the retain kits vidas msg lot 1005989450 / 180726-0. The results of calibration were in conformance to the mle data and all samples were within specifications. Conclusion: according the data above, the vidas msg kit, lot 1005989450 / 180726-0vm is within the expected performances. Additionally, quality controls are not identical to patient samples, as the qc manufacturing process can affect sample matrix and control results. According to complaints trend analysis, there is no current reason to suspect a product issue on vidas msg. The problem seems to be linked to this particular quality control with vidas msg reagent. Without customer's return sample, no further investigation can be performed nor proposal of a root cause to the customer issue.
Patient Sequence No: 1, Text Type: N, H10
[117865724]
A customer in (b)(6) notified biom? Rieux of false negative results when testing with vidas? Measles igg (msg), ref 30219, for a lab quality campaign. For the sample (b)(6), the customer obtained on the vidas 3 instrument : first result, test value =0. 48, negative. Second result (repetition of the test), test value= 0. 42 negative. The result expected for this sample was positive. The expected interpretation for s002 was old immunity or vaccinated on lab quality's report. Concerning this lab quality campaign, there were 50 participants. The results were : eight (8) of them reported a negative result. Four (4) of them reported borderline result. And 38 reported positive result. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00150 |
| MDR Report Key | 7794435 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-17 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2017-09-26 |
| Date Added to Maude | 2018-08-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 376 CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIDAS? MEASLES IGG |
| Generic Name | VIDAS? MSG |
| Product Code | LJB |
| Date Received | 2018-08-17 |
| Catalog Number | 30219 |
| Lot Number | 1005989450 |
| Device Expiration Date | 2018-07-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | 376 CHEMIN DE L ORME MARCY L ETOILE, 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |