MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2007-09-06 for CELL-DYN 22 CALIBRATOR 99120-01 manufactured by Abbott Laboratories.
[21384099]
The customer stated the cell-dyn 3200 sl analyzer generated an elevated platelet result after performing calibration on the instrument with cell-dyn 22 calibrator lot 3098. The customer adjusted the platelet parameter on the instrument and recalibrated. No pt data was provided by the customer. There was no impact to pt management reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[21431069]
Platelet recovery values were out of range high during stability testing for the cell-dyn 22 calibrators, lots 3099, 3098, and 3100 and cell-dyn 22 control lot 0125 for the cd3200 and/or cd ruby optical analyzers. Cell-dyn 22 calibrator lot 3098 did not meet shelf life stability on the cell-dyn 3200 analyzer at its expiry. Cell-dyn 22 calibrator lot 3099 did not met shelf life stability and the 7 day open vial stability for the platelet parameter on the cell-dyn ruby analyzer. Internal data indicated that cell-dyn 22 calibrator lot 3100 was experiencing the same issues as it approached the october 6, 2006 expiration date. Cell-dyn 22 calibrators and controls are subjected to stability testing per abbott department operating procedures. The cell-dyn 22 calibrators and controls claim product shelf life and consecutive day open container stability. The calibrator and control values must meet the requirement within the published assay values and ranges per abbott stability testing parameters. The values recovered during stability testing are the same as product release values. An investigation was performed and probable causes were found to be a combination of the following issues: common cause process variability of the red blood cell fragmentation to platelet like particles affecting mean platelet volume, and special cause variation of tightening the platelet specification by 50%. It was determined that red blood cell fragmentation is enhanced by mechanical stress. These issues did not adequately predict an increase of platelet count through the established stability claims. The formulation and manufacturing process used in the manufacturing and testing of the cell-dyn 22 calibrators and controls are specific to both the calibrators and controls and does not impact the other instrument platforms, therefore, the identified probable cause is product specific. The corrective action for the cell-dyn 22 calibrators and controls is to re-evaluate the platelet specification, improve assay assignment procedure for platelet parameter, re-validate the platelet manufacturing process to increase the mean platelet volume and conduct monthly value assignment. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919069-2007-00136 |
| MDR Report Key | 907941 |
| Report Source | 01,04 |
| Date Received | 2007-09-06 |
| Date of Report | 2007-02-26 |
| Date of Event | 2006-10-06 |
| Date Mfgr Received | 2007-02-26 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-10-19 |
| 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 | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 |
| 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 | 2007-09-06 |
| Model Number | NA |
| Catalog Number | 99120-01 |
| Lot Number | 3098 |
| ID Number | NA |
| Device Expiration Date | 2006-08-06 |
| Operator | OTHER |
| 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 | 900947 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 5440 PATRICK HENRY DR. SANTA CLARA CA 95054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-06 |