MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-12-28 for THXID? BRAF 410697 manufactured by Biomerieux Sa.
[63621005]
A customer in united states notified biom? Rieux of a product problem when using the thxid braf product. The customer reported after dilution of the positive control with 150 l as specified in the protocol, the nano drop quantity is around 2 ng/ l and the assay failed with an invalid positive control. The customer reported diluting the positive control with less volume (50 l), the nano drop reading is around 7 ng/ l. The assay did function correctly with a higher concentrated positive control. Due to the repeat testing before using another assay, the customer indicated a delay in reporting results. There is no indication or report from the customer that the product problem led to any adverse event related to the patient's state of health. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[69042374]
Biom? Rieux conducted an internal investigation: several tests were performed internally in order to check the performance of the product. A total of (b)(4) pc were tested and the results were within the expected specifications. Also, customer returned samples were analyzed and during the investigation it was noted that there was no fluorescence for both runs and for both targets (v600e and v600k) which is rare for the internal control. The discrepancy observed by the customer is likely due to handling or equipment used by the customer. It is recommended that the customer consult with the biom? Rieux local representative regarding handling steps described in the instruction for use, especially: - after addition of 150? L of positive control diluent to the positive control sphere, mix at full speed using a vortex-type mixer until a clear solution has been obtained. - after addition of the 2? L of positive control: several aspiration/dispensing with the pipette are necessary to allow a good homogenization of the pc in the mix. We advise to count a minimum of 5 aspiration/dispensing. Since the root cause of the discrepancy is related to use error no corrective action is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00533 |
| MDR Report Key | 6211049 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-12-28 |
| Date of Report | 2017-02-21 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2016-12-28 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THXID? BRAF |
| Generic Name | THXID? BRAF |
| Product Code | OWD |
| Date Received | 2016-12-28 |
| Catalog Number | 410697 |
| 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 | 2016-12-28 |