MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-21 for PASCO MICRO-ORGANISM SUSCEPTIBILITY SYSTEM manufactured by Difco.
[19891260]
The interpretations which appear on the attached lis report, therefore are not provided by the pasco software. Conclusion is that the erroneous interpretations were loaded into co's system by the microbiology lab personnel of st. Joseph hosp. Co recommended that all results and associated interpretations and messages be carefully reviewed before changes are made or reports are released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005699 |
| MDR Report Key | 21385 |
| Date Received | 1995-04-21 |
| Date of Report | 1995-02-02 |
| Date of Event | 1995-02-02 |
| Date Added to Maude | 1995-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASCO MICRO-ORGANISM SUSCEPTIBILITY SYSTEM |
| Generic Name | SOFTWARE |
| Product Code | LKA |
| Date Received | 1995-04-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21422 |
| Manufacturer | DIFCO |
| Manufacturer Address | DETROIT MI 483237058 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-04-21 |