MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-22 for VERSATREK REDOX EZ DRAW PURPLE AEROBIC 7106-44 * manufactured by Thermo Fisher Scientific Microbiology Americas.
[17102439]
A blood culture collected went positive and the gram stain showed gram positive cocci in chains. The specimen was plated to agar plates per protocol. After 24 hours, no organism grew. Selective media was then inoculated and incubated 24 hours in order to get the organism to grow. Two days after the initial positive report microbiology determined the organism was not viable, amended report and reported as no growth. Since that time, microbiology has recorded that this report was a false positive. We have had a total of six false positives blood cultures, five of which were from the same lot number of redox ezdraw aerobic bottles lot 154777sa. None of these false positives were reported on patients. Microbiology gram stained some of the un-inoculated blood culture broths from the lot number in question and verified that the "organism" is present in the bottle before patient sample is added. This false positive may have caused the patient to be hospitalized and treated with antibiotics needlessly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2467633 |
| MDR Report Key | 2467633 |
| Date Received | 2012-02-22 |
| Date of Report | 2012-02-22 |
| Date of Event | 2012-02-13 |
| Report Date | 2012-02-22 |
| Date Reported to FDA | 2012-02-22 |
| Date Added to Maude | 2012-02-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSATREK REDOX EZ DRAW PURPLE AEROBIC |
| Generic Name | AEROBIC BLOOD CULTURE BOTTLE |
| Product Code | JSC |
| Date Received | 2012-02-22 |
| Model Number | 7106-44 |
| Catalog Number | * |
| Lot Number | 154777SA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERMO FISHER SCIENTIFIC MICROBIOLOGY AMERICAS |
| Manufacturer Address | 12076 SANTA FE TRAIL LENEXA KS 66215 US 66215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-22 |