MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2001-06-22 for HNID PANEL B1012-10B manufactured by Dade Microscan, Inc..
[228749]
User reported a clinical isolate was identified on microscan hnid panel read by the walkaway instrument system as neisseria gonorrhoeae with 99% probability. The specimen was from a blood source from pt. Due to the unusual source for this organism the specimen was sent to the state health dept reference lab for confirmation. The state reference lab identified the organism as neisseria meningitidis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2001-00002 |
| MDR Report Key | 339271 |
| Report Source | 00,05 |
| Date Received | 2001-06-22 |
| Date of Report | 2001-06-22 |
| Date of Event | 2001-04-12 |
| Date Mfgr Received | 2001-05-30 |
| Date Added to Maude | 2001-06-28 |
| 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 | 0 |
| Manufacturer Contact | MAUREEN MENDE |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743174 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HNID PANEL |
| Generic Name | IDENTIFICATION TEST PANEL FOR HAEMOPHILUS AND NEISSERIS |
| Product Code | LRH |
| Date Received | 2001-06-22 |
| Model Number | NA |
| Catalog Number | B1012-10B |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 328578 |
| Manufacturer | DADE MICROSCAN, INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95831 US |
| Baseline Brand Name | HNID PANEL |
| Baseline Generic Name | HAEMOPHILUS NEISSERIA IDENTIFICATION PANEL |
| Baseline Model No | NA |
| Baseline Catalog No | B1012-10B |
| Baseline ID | NA |
| Baseline Device Family | RAPID CHROMAGENIC IDENTIFICATION PANELS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 10 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833027 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-22 |