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 2018-04-05 for VITEK? 2 GRAM POSITIVE ID TEST KIT 21342 manufactured by Biomerieux Inc..
[104859025]
A customer from (b)(6) notified biom? Rieux of a misidentification of an isolate when testing with vitek? 2 gp id test kit. The isolate colonies were pale pink on chromid? Cps elite. Vitek 2 identified the isolate as staphylococcus saprophyticus with 99% of probability from chromid cps. On a fosfomycin antibiogram, the isolate was susceptible (mic value >8) instead of resistant (antibiogram not consistent). The customer performed a fosfomycin disc on mueller hinton (mh) agar: result was again susceptible. The customer retested the isolate with the vitek 2 gp card from mh agar. The result was 96% s. Saprophyticus, and the antibiogram was fosfomycin susceptible (again not consistent). After that, the customer performed rapidec staph strip and concluded the organism was not s. Saprophyticus and not s. Aureus. The customer reported coagulase negative staphylococcus because they were unable to get a definitive id. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. The customer stated there was a delay of greater than 24 hours in reporting the patient results. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00132 |
| MDR Report Key | 7398891 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-05 |
| Date of Report | 2018-08-02 |
| Date Mfgr Received | 2018-07-10 |
| Device Manufacturer Date | 2017-12-19 |
| Date Added to Maude | 2018-04-05 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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 | VITEK? 2 GRAM POSITIVE ID TEST KIT |
| Generic Name | VITEK? 2 GP ID TEST KIT |
| Product Code | LQL |
| Date Received | 2018-04-05 |
| Catalog Number | 21342 |
| Lot Number | 2420571103 |
| Device Expiration Date | 2019-06-20 |
| 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 INC. |
| Manufacturer Address | 595 ANGLUM ROAD SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-05 |