MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-12-01 for CELL-DYN 22 CALIBRATOR 99120-01 manufactured by Abbott Diagnostics Division/celldyn.
[580713]
The account stated that platelet qc was out of range high on their cd3200 sl analyzer. They were not using this analyzer for patient testing as they were still performing correlations. They stated that they had calibrated the analyzer with cell-dyn 22 calibrator lot 3100.
Patient Sequence No: 1, Text Type: D, B5
[8057270]
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. Investigation into the cause of this instability is in progress. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919069-2006-00110 |
| MDR Report Key | 789655 |
| Report Source | 06 |
| Date Received | 2006-12-01 |
| Date of Report | 2006-09-28 |
| Date Mfgr Received | 2006-09-28 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2006-12-06 |
| 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 ROAD |
| 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 | 2006-12-01 |
| Model Number | NA |
| Catalog Number | 99120-01 |
| Lot Number | 3100 |
| ID Number | NA |
| Device Expiration Date | 2006-10-06 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 777330 |
| 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 | 2006-12-01 |