MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-01-07 for MRSA SCREEN AGAR 4321952 manufactured by Becton Dickinson Microbiology Systems.
[74666]
This cusotmer has recently had numerous pt organisms whose vitek and mrsa screen agar results do not correlate. The vitek results have been reading at>8, yet the same isolates showed no growth on the mrsa screen agar plate. Quality control with the recommended organism, atcc 43300, was satisfactory. The customer is unsure if vitek, or the mrsa screen agar is the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1997-00013 |
| MDR Report Key | 142464 |
| Report Source | 05,06 |
| Date Received | 1998-01-07 |
| Date of Report | 1997-12-18 |
| Date of Event | 1997-08-25 |
| Date Facility Aware | 1997-08-25 |
| Report Date | 1997-12-18 |
| Date Mfgr Received | 1997-08-25 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1998-01-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRSA SCREEN AGAR |
| Generic Name | PREPARED PLATED MEDIA |
| Product Code | JTZ |
| Date Received | 1998-01-07 |
| Model Number | NA |
| Catalog Number | 4321952 |
| Lot Number | G3NXXL |
| ID Number | * |
| Device Expiration Date | 1997-08-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 138950 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Baseline Brand Name | MRSA SCREEN AGAR |
| Baseline Generic Name | PREPARED PLATED MEDIA |
| Baseline Model No | NA |
| Baseline Catalog No | 4321952 |
| Baseline ID | G3NXXL |
| Baseline Device Family | PREPARED PLATED MEDIA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 3 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K863821 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-07 |