MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-10-09 for CHLAMYDIAZYME EIA 1803-30 manufactured by Abbott Laboratories.
[295201]
The account generated negative chlamydiazyme eia results, reagent lot 04572m100, on 18 patients that tested bsa slide technique positive. This report is for patient 17 of the 18 total patients. Although the control values were acceptable, the account noticed a big drop in the positive result values. The account retested the patients using chlamydiazyme eia reagent lot 03228m100 with the expected positive results. Amended reports were submitted to the physicians. It is unknown if there was impact to patient management. No patient information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2003-00026 |
| MDR Report Key | 489506 |
| Report Source | 06 |
| Date Received | 2003-10-09 |
| Date of Report | 2003-10-08 |
| Date of Event | 2003-09-10 |
| Date Mfgr Received | 2003-09-11 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2003-10-20 |
| 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 | DR. DAVID SPINDELL |
| Manufacturer Street | 100 ABBOTT PARK ROAD D-09Y6, AP6C-2 |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHLAMYDIAZYME EIA |
| Generic Name | EIA FOR THE DETECTION OF CHLAMYDIA ANTIGEN |
| Product Code | LJC |
| Date Received | 2003-10-09 |
| Model Number | NA |
| Catalog Number | 1803-30 |
| Lot Number | 04572M100 |
| ID Number | NA |
| Device Expiration Date | 2003-12-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 478255 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | CHLAMYDIAZYME DIAG KIT 500T WITH ACCESSORIES |
| Baseline Generic Name | EIA FOR THE DETECTION OF CHLAMYDIA ANTIGEN |
| Baseline Model No | NA |
| Baseline Catalog No | 1803-30 |
| Baseline Device Family | CHLAMYDIAZYME ENZYME IMMUNOASSAY |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 10 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900543 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-10-09 |