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 2018-03-27 for ETEST? DAPTOMYCIN DPC 256 WW F100 535018 manufactured by Biomerieux Sa.
[103947499]
A customer from (b)(6) reported out of range low results for internal quality controls (qc) in association with etest? Daptomycin dpc 256 ww f100 (reference 535018) lot 1004343910. The customer stated that when their qc is within range it is always at the very lowest end of the qc range for both the staphylococcus aureus atcc? 29213 and enterococcus faecalis atcc? 29212. The customer reported that when the qc is out of range, it is always lower than expected. The customer reported that results were delayed at least 72 hours for two (2) patients (with vre in the blood) due to the daptomycin qc failing at least twice. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to a patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00048 |
| MDR Report Key | 7374662 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-27 |
| Date of Report | 2018-06-19 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2018-03-27 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? DAPTOMYCIN DPC 256 WW F100 |
| Generic Name | ETEST? DAPTOMYCIN DPC 256 WW F100 |
| Product Code | JWY |
| Date Received | 2018-03-27 |
| Catalog Number | 535018 |
| Lot Number | 1004343910 |
| Device Expiration Date | 2018-10-01 |
| 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 | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE 383 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-27 |