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 2016-08-18 for VIDAS? LYME IGG 30320 manufactured by Biomerieux Sa.
[52736348]
A customer in (b)(6) contacted biomerieux to report a false negative result in association with the vidas lyme igg assay. The patient sample was sent to a reference laboratory; testing via western blot (wb) method provided a positive result. All results were provided to the treating physician. The customer was not able to provide information regarding the clinical status of the patient. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to the patient's state of health. Culture submittal was requested by biomerieux for internal investigation. However, the customer stated the sample is no longer available. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[58728803]
An investigation into a (b)(6) result event while using the vidas? Lyme igg test kit was performed. The customer obtained a (b)(6) result with the vidas? Lyme igg test kit. Testing at a reference lab by western blot provided a (b)(6) result. The patient sample was not returned for investigational testing; therefore, this complaint could not be confirmed. Three quality control samples near the cutoff value were run on retain samples from the lot involved within this complaint. All results were within expected values. A review of the batch production record and original quality control release testing was performed. No related anomalies or abnormalities were found. Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00149 |
| MDR Report Key | 5886428 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-18 |
| Date of Report | 2016-07-22 |
| Date Mfgr Received | 2016-07-22 |
| Device Manufacturer Date | 2015-12-16 |
| Date Added to Maude | 2016-08-18 |
| 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? LYME IGG |
| Generic Name | VIDAS? LYME IGG |
| Product Code | LSR |
| Date Received | 2016-08-18 |
| Catalog Number | 30320 |
| Lot Number | 1004526300 |
| Device Expiration Date | 2016-11-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-08-18 |