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 2017-03-29 for ETEST? TICARCILLIN CLAVULANIC ACID 522658 manufactured by Biom?rieux Sa.
[71325087]
A customer in the united states reported a discrepant result (out-of-range-low) for eubacterium lentum atcc 43055, associated with etest? Ticarcillin clavulanic acid tic/clav-con2 tlc 256 us f100. The customer reported obtaining an out of range lower mic. The expected values between 16 - 64 and the mic result obtain was 4 - 8. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There may be a potential for adverse event if the event were to reoccur while testing a patient isolate; therefore this event is being reported as a malfunction. Culture submittal was requested by biom? Rieux for internal investigation. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00056 |
| MDR Report Key | 6441962 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-29 |
| Date of Report | 2017-08-23 |
| Date Mfgr Received | 2017-07-28 |
| Date Added to Maude | 2017-03-29 |
| 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 | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? TICARCILLIN CLAVULANIC ACID |
| Generic Name | ETEST? TICARCILLIN CLAVULANIC ACID |
| Product Code | JWY |
| Date Received | 2017-03-29 |
| Catalog Number | 522658 |
| Lot Number | 1004598840 |
| Device Expiration Date | 2019-01-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-29 |