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 2016-09-20 for VIDAS? MEASLES IGG 30219 manufactured by Biomerieux Sa.
[55161018]
A customer in the (b)(6) contacted biomerieux to report the occurrence of false negative and false equivocal results in association with the vidas measles igg assay. Testing of specimens by reference laboratory obtained a result of positive. The customer stated that two (2) results from the referenced lot were confirmed as false negative. Initial results were 0. 37 and 0. 49 indicating a negative which were later confirmed as a positive. The customer indicated delays of between 10-14 days when a false negative is reported, which will delay treatment as the customer is sending all negatives to a different hospital. There is no indication or report from the laboratory that the discrepant results 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
[61669263]
A customer in (b)(6) contacted biom? Rieux to report the occurrence of false negative and false equivocal results in association with the vidas? Measles igg assay. An internal biom? Rieux investigation was performed. Results are as follows: the customer's sample was not submitted. Since october 2015, there is no other complaint related sensitivity problem for vidas? Msg batch 1004802610 / 170302-0. There is no capa, nor non conformity for a similar issue in relation to the customer's complaint. The analysis of the batch history records showed that four (4) samples were out of range but these samples were found within their interpretation. During the quality control process, a specificity control was performed on 28 negative sera and 54 positive sera. All sera were found within their specifications. The analysis of the control card of each sample tested showed that vidas? Msg batch 170302-0 was in the trend with the other batches. The quality product laboratory tested two (2) internal negative and two (2) internal positive samples on the retain kit vidas? Msg batch 1004802610 / 170302-0. The results obtained for the four (4) samples were within their specifications. The performance of vidas? Msg batch 170302-0 are within the expected specifications indicated in the package insert.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00343 |
| MDR Report Key | 5963708 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-20 |
| Date of Report | 2016-08-23 |
| Date Mfgr Received | 2016-08-23 |
| Device Manufacturer Date | 2016-04-18 |
| Date Added to Maude | 2016-09-20 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| 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? MEASLES IGG |
| Generic Name | VIDAS? MEASLES IGG |
| Product Code | LJB |
| Date Received | 2016-09-20 |
| Catalog Number | 30219 |
| Lot Number | 1004802610 |
| Device Expiration Date | 2017-03-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-09-20 |