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 CELL-DYN 22 CALIBRATOR 99120-01 manufactured by Abbott Diagnostics Division/celldyn.
[20508428]
On-market instability for platelets with cell-dyn 22 calibrator lots 3098 and 3099 is being experienced. The calibrator could read higher by at least 10% on the cell-dyn ruby and as much as 22% on the cell-dyn 3200. If this calibrator is used and the calibration factor on the instrument is adjusted, a negative platelet sample bias could result. As a precaution, lot 3100 was also removed from use. A recall was issued and reported under 21 cfr 806 to the fda district office on 09/26/2006. Abbott has not received any reports of adverse events related to the affected lots of cell-dyn 22 calibrators.
Patient Sequence No: 1, Text Type: D, B5
[20810544]
Investigation to determine the cause of the stability issue is ongoing. This is a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919069-2006-00118 |
| MDR Report Key | 793883 |
| Report Source | 07 |
| Date Received | 2006-12-04 |
| Date of Event | 2006-09-18 |
| Date Added to Maude | 2006-12-14 |
| 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 | 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 | 2919069-9/26/06-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELL-DYN 22 CALIBRATOR |
| Generic Name | CD22 CALIBRATOR |
| Product Code | KRZ |
| Date Received | 2006-12-04 |
| Model Number | NA |
| Catalog Number | 99120-01 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 781500 |
| Manufacturer | ABBOTT DIAGNOSTICS DIVISION/CELLDYN |
| Manufacturer Address | 5440 PATRICK HENRY DR. SANTA CLARA CA 95054 US |
| Baseline Brand Name | CELL-DYN 22 CALIBRATOR |
| Baseline Generic Name | CD22 CALIBRATOR |
| Baseline Model No | NA |
| Baseline Catalog No | 99120-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-04 |