MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-13 for COULTER LH 750 6605632 manufactured by Beckman Coulter, Inc..
[369419]
A customer contacted beckman coulter regarding a possible sample misidentification when runnning pt sample on coulter lh 750 instrument in 2005. The results for pt a were printed with pt b demographics. The customer indicated that the sample of pt b was tested on this instrument in the past (12/04) with the same id as pt a. The misidentification was noted by the customer during sample a comparison with the lab information system (lis) computer data. The customer indicated that sample ids are re-cycled every 8 weeks, but ids are never re-cycled in their lab. The customer indicated that the auto-delete option was enabled at the time of this event. It was set to delete automatically, every 24 hours, all samples from a to do list entry and all completed samples. The customer did not provide any additional information regarding this event. The customer indicated that there has been no change to pt treatment attributed to or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2005-00014 |
| MDR Report Key | 591607 |
| Report Source | 05 |
| Date Received | 2005-04-13 |
| Date of Report | 2005-04-13 |
| Date of Event | 2005-02-21 |
| Date Mfgr Received | 2005-03-16 |
| Device Manufacturer Date | 2003-10-01 |
| Date Added to Maude | 2005-04-18 |
| 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 | NANCY JOHNSON, MGR T |
| Manufacturer Street | 200 S.KRAEMER BOULEVARD P.O BOX 8000, MAIL STOP: W-110 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149614489 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER LH 750 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKH |
| Date Received | 2005-04-13 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 581477 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US |
| Baseline Brand Name | COULTER LH 750 |
| Baseline Generic Name | HEMATOLOGY ANALYZER |
| Baseline Model No | LH 750 |
| Baseline Catalog No | 6605632 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-13 |