MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-17 for CELL-DYN 22 CALIBRATOR 99120-01 manufactured by Abbott Diagnostics Division/celldyn.
[663691]
The customer stated after calibrating the cell-dyn 3200 analyzer the platelet qc is out of range, high. The customer was advised of the recall of cell-dyn control lot 3100. The customer was further instructed to reset the platelet calibrator factors back to the parameters prior to controls out of range high, recalibrate and re-assay with a different lot of controls. The platelet qc out of range issue was resolved by calibration with a fresh, properly stored calibrator. The customer reported that there was no further issues and they were satisfied with the performance of the instrument and the controls.
Patient Sequence No: 1, Text Type: D, B5
[7853937]
An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919069-2007-00125 |
| MDR Report Key | 897743 |
| Report Source | 05 |
| Date Received | 2007-08-17 |
| Date of Report | 2007-05-03 |
| Date of Event | 2006-09-19 |
| Date Mfgr Received | 2007-05-03 |
| Date Added to Maude | 2007-10-01 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARTCH, 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 |
| 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 | 2007-08-17 |
| Model Number | NA |
| Catalog Number | 99120-01 |
| Lot Number | 3100 |
| ID Number | 3098 |
| Device Expiration Date | 2006-10-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 878397 |
| Manufacturer | ABBOTT DIAGNOSTICS DIVISION/CELLDYN |
| Manufacturer Address | 5440 PATRICK HENRY DRIVE SANTA CLARA CA 95054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-17 |