MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-21 for VIDAS? B?R?A?H?M?S PCT (TM) 30450-01 manufactured by Biomerieux Sa.
[29296719]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[29296720]
On (b)(6), 2015 customer called to report an issue related to the negative range (false negative) when using product vidas b? R? A? H? M? S pct (tm) (pct), (b)(4), lot 1004045770. Upon retesting samples results were positive. Test results as follows: initial rfv = -2, result = <0. 05 : repeat rfv = 6, result = 0. 08. Second set of values : initial rfv = -2, result = <0. 05 : repeat rfv = 323, result = 3. 60. Customer reported no patient was harmed or treated incorrectly.
Patient Sequence No: 1, Text Type: D, B5
[30121764]
Internal investigation was conducted. The analysis of the vidas? Pct batch 1004045770 indicates no anomalies associated with the number of negative samples tested by the qc laboratory. For the investigation , eleven (11) negative samples were tested using batch 1004045770. Three (3) negative samples were obtained (relative fluorescence values at -1) with no change in interpretation. These negative rfv values near 0 do not indicate a lack of sensitivity. The discrepant results obtained by the customer are not due to negative rfv values. The performance of the batch vidas? Pct 1004045770 is within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00124 |
| MDR Report Key | 5163755 |
| Date Received | 2015-10-21 |
| Date of Report | 2015-10-02 |
| Date Mfgr Received | 2015-10-02 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2015-10-21 |
| 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 |
| 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? B?R?A?H?M?S PCT (TM) |
| Generic Name | VIDAS? B?R?A?H?M?S PCT (TM) |
| Product Code | NTM |
| Date Received | 2015-10-21 |
| Catalog Number | 30450-01 |
| Lot Number | 1004045770 |
| Device Expiration Date | 2016-05-17 |
| 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 | 2015-10-21 |