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 2018-03-16 for API? 20E TEST STRIP 20100 manufactured by Biomerieux Sa.
[103157940]
A customer in (b)(6) contacted biom? Rieux to report the occurrence of a misidentification of raoultella planticola (external qc strain) as klebsiella pneumonia in association with the api? 20e test. No alternate test method or confirmatory testing was performed by the customer. The external qc testing was performed one year ago; the strain is no longer available for retest. Prior to 2001, the name of raoultella planticola was klebsiella planticola. The biochemical characteristics between raoultella planticola and klebsiella pneumonia are similar. It is important to note that raoultella planticola is not in the api? 20e database; therefore, it is not possible to identify raoultella planticola theapi? 20e test strip. 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 was no patient directly associated with the qc strain. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00042 |
| MDR Report Key | 7344955 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-16 |
| Date of Report | 2018-04-23 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-03-16 |
| 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 | API? 20E TEST STRIP |
| Generic Name | API? 20E TEST STRIP |
| Product Code | JSS |
| Date Received | 2018-03-16 |
| Catalog Number | 20100 |
| 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 | 2018-03-16 |