MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-15 for COULTER LH 750 6605632 manufactured by Beckman Coulter, Inc..
[435989]
A customer contacted beckman coulter regarding a mismatch of 2 different pt results when running patient samples on coulter lh 750 instrument. The customer indicated that pt a was an er patient at hospital, and patient b an another hospital. The samples of pt a and b were tested for cbc on coulter lh 750 instrument. The customer indicated that pt b results were flagged and required a review. When reviewing the results of pt b, the customer noticed that the screeen had pt b accession number but name of pt a. During further investigation the customer discovered that all results for pt a or b were listed under pt a. The customer indicated that there had been no change to pt treatment attributed to or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2005-00024 |
| MDR Report Key | 621745 |
| Report Source | 05 |
| Date Received | 2005-07-15 |
| Date of Report | 2005-07-15 |
| Date of Event | 2005-06-17 |
| Date Mfgr Received | 2005-06-17 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2005-07-20 |
| 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, GROUP MANAGER |
| Manufacturer Street | 200 S. KRAEMER BOULEVARD PO 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 | 2005-07-15 |
| Model Number | LH 750 |
| Catalog Number | 6605632 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 611393 |
| 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 | 2005-07-15 |