MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-03-20 for BIO RAD ANCA FORMALIN FIXED IFA SLIDE 29418 manufactured by Immco Diagnostics, Inc..
[18044521]
Immco diagnostics, inc. Has identified that the formalin fixed anca slide, approximately nine (9) months after manufacture has lost reactivity for the detection of canca and panca antibodies prior to expiration. The likely root cause is lot specific defect in donor hpmn cells used as the reactive substrate causing degradation of reactivity prior to labeled expiration date. As this test is used as a secondary, confirmatory method for perinuclear anca reactions and the internal quality controls required in the instructions for use and provided for use with this slide will fail on this slides prompting retest; this issue has been classified as no risk to patient health. Immediate field correction has been taken to replace slides of this lot used in the anca test system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1315336-2012-00001 |
| MDR Report Key | 2498582 |
| Report Source | 08 |
| Date Received | 2012-03-20 |
| Date of Report | 2012-03-20 |
| Date of Event | 2012-01-03 |
| Date Mfgr Received | 2012-01-03 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-08-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 60 PINEVIEW DR. |
| Manufacturer City | BUFFALO NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166910091 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO RAD ANCA FORMALIN FIXED IFA SLIDE |
| Generic Name | FORMALIN FIXED HUMAN PMN CELLS |
| Product Code | MOB |
| Date Received | 2012-03-20 |
| Model Number | 29418 |
| Catalog Number | 29418 |
| Lot Number | 1103404 |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMCO DIAGNOSTICS, INC. |
| Manufacturer Address | BUFFALO NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-20 |