MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-05-23 for HNID PANEL * B1012-10B manufactured by Dade Behring Inc..
[381235]
User reported a clinical isolate was run on an organism isolated post-mortem to determine cause of death. An identification of n. Gonorrhoeae was obtained on the microscan hnid panel, while an alternate method identified the isolate as n. Meningitidis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919016-2005-00003 |
| MDR Report Key | 609434 |
| Report Source | 05 |
| Date Received | 2005-05-23 |
| Date of Report | 2005-05-19 |
| Date of Event | 2005-04-14 |
| Date Mfgr Received | 2005-04-22 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2005-06-03 |
| 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 | 0 |
| Manufacturer Contact | JOSE UNTALAN |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163743285 |
| Manufacturer G1 | * |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HNID PANEL |
| Generic Name | IDENTIFICATION TEST PANEL FOR HAEMOPHILIS AND NEISSERIA |
| Product Code | LRH |
| Date Received | 2005-05-23 |
| Model Number | * |
| Catalog Number | B1012-10B |
| Lot Number | 2005-10-30 |
| ID Number | * |
| Device Expiration Date | 2005-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 599243 |
| Manufacturer | DADE BEHRING INC. |
| Manufacturer Address | 2040 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691 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 | 2005-05-23 |