MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-12-04 for XSYSTEMS CA 15-3 CONTROLS 9C08-10 manufactured by Abbott Laboratories.
[545374]
This medwatch report is being filed due to an increased number of invalid runs due to controls outside the package insert range with this lot of ca 15-3 controls. Control results outside the package insert range would result in an invalid run. A recall was issued and reported on june 9, 2006. Abbott has not received any reports of adverse events related to this issue.
Patient Sequence No: 1, Text Type: D, B5
[8053431]
This is a final report. An investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2006-00043 |
| MDR Report Key | 794406 |
| Report Source | 07 |
| Date Received | 2006-12-04 |
| Date of Event | 2006-06-09 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-12-15 |
| 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 | DR DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1244-06 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XSYSTEMS CA 15-3 CONTROLS |
| Generic Name | CA 15-3 CONTROLS |
| Product Code | JFP |
| Date Received | 2006-12-04 |
| Model Number | NA |
| Catalog Number | 9C08-10 |
| Lot Number | 29506M100 |
| ID Number | NA |
| Device Expiration Date | 2006-07-05 |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 782027 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | XSYSTEMS CA 15-3 CONTROLS |
| Baseline Generic Name | CA 15-3 CONTROLS |
| Baseline Model No | NA |
| Baseline Catalog No | 9C08-10 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-04 |