MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1998-06-26 for NEUTROPHIL SLIDE 508290 manufactured by Inova Diagnostics, Inc..
[16031121]
The customer in france purchased some components of the nova lite anca(anti-neutrophil cytoplasmic antibody) kit from a french distributor. The componenet that make up the kit are pbs concentrate, mounting media, "canca" positive, "panca" positive, conjugate, negative control and ethanol-fixed neutrophil slides. The customer purchased and used the following components of inova's device to perform the test: neutrophil slides,lot number 722939; and fitc-igg conjugate, lot 722737. These components were used with other components that are not manufactured by inova such as pbs. The pbs solution required to perform the test was prepared by the customer's lab. The patient went to the rheumatologist. The rheumatologist suspected wegener's granulomatosis is based on clinical symptoms and requested "anca" test. The technician requested the patient sample using the neutrophil slides on march 30,1998 and interpreted the result as negative. The biologist ran it on a different day and interpreted it as a weak positive. The patient was sent to nephrology. The clinicain requested an "anca" test. The test was performed using "bmd" and bioadvanced "anca" ethanol slides and the results were interpreted as positive "anac. " the patient was put on corticotherapy. The patient died in april 1998. Post mortem biopsy confirmed wegener's granulimatosis disease and cresentic nephritis glomerulonephritis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2026994-1998-00001 |
| MDR Report Key | 174132 |
| Report Source | 01,08 |
| Date Received | 1998-06-26 |
| Date of Report | 1998-06-25 |
| Date of Event | 1998-04-01 |
| Date Mfgr Received | 1998-06-01 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 1998-06-29 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUTROPHIL SLIDE |
| Generic Name | ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY SLIDES |
| Product Code | MOB |
| Date Received | 1998-06-26 |
| Model Number | NA |
| Catalog Number | 508290 |
| Lot Number | 722939 |
| ID Number | NA |
| Device Expiration Date | 1999-05-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 169300 |
| Manufacturer | INOVA DIAGNOSTICS, INC. |
| Manufacturer Address | 10180 SCRIPPS RANCH BLVD. SAN DIEGO CA 921311234 US |
| Baseline Brand Name | COMPONENT BRAND NAME NEUTROPHIL SLIDE |
| Baseline Generic Name | COMPONENT GENERIC NAME ANCA SLIDE |
| Baseline Model No | NA |
| Baseline Catalog No | 508290 |
| Baseline ID | LOT NUMBER - 72 |
| 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 | 1998-06-26 |