MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2000-07-13 for ANCA SLIDE 508297 manufactured by Inova Diagnostics, Inc..
[181597]
Diagnostica, inova diagnostics, inc. 's austrian distributor, reported that one of their customers indicated that the formalin fixed, 12-well neutrophil slides, (part number 508297, lot number 922515) are too sensitive. A pt presented symptoms of pulmo-renal insufficiency and was being seen in nephrology. The nephrologist sent the pt sample to the lab. A temporary tech ran the pt sample on the anca test using both the formalin fixed slides(508297, 922515) and the ethanol fixed slides(508296, 022268). The tech used the pbs solution prepared by their lab and not the pbs solution mfg by inova diagnostics required for the anca test. The tech read the formalin fixed slides as positive and the ethanol fixed slides as negative. The initial result reported from the test lab in austria was anca positive. The pt was immediately treated with endoxan based on this preliminary result. Further tests performed the following day on the ethanol fixed slide from inova and the pr3 and mpo elisa tests from wieslab indicated negative results. The austrian distributor indicated in her fax to inova that "the pt will probably not survive the week".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2026994-2000-00001 |
| MDR Report Key | 285488 |
| Report Source | 01,08 |
| Date Received | 2000-07-13 |
| Date of Report | 2000-07-13 |
| Date of Event | 2000-01-01 |
| Date Mfgr Received | 2000-06-21 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 2000-07-14 |
| 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 | DONNA GUSTAFSON, VP DEV&QS |
| Manufacturer Street | 10180 SCRIPPS RANCH BLVD |
| Manufacturer City | SAN DIEGO CA 921311234 |
| Manufacturer Country | US |
| Manufacturer Postal | 921311234 |
| Manufacturer Phone | 8585869900 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCA SLIDE |
| Generic Name | FORMALIN FIXED HUMAN NEUTROPHIL SLIDE |
| Product Code | MOB |
| Date Received | 2000-07-13 |
| Model Number | NA |
| Catalog Number | 508297 |
| Lot Number | 922515 |
| ID Number | NA |
| Device Expiration Date | 2000-12-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 276274 |
| Manufacturer | INOVA DIAGNOSTICS, INC. |
| Manufacturer Address | 10180 SCRIPPS RANCH BLVD. SAN DIEGO CA 921311234 US |
| Baseline Brand Name | COMPONENT BRAND NAME ANCA SLIDE |
| Baseline Generic Name | COMPONENT GENERIC NAME ANCA SLIDE |
| Baseline Model No | NA |
| Baseline Catalog No | 508297 |
| Baseline ID | LOT NUMBER - 92 |
| Baseline Device Family | NOVA LITE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961340 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2000-07-13 |