MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-03-26 for DATALINK 464800 manufactured by Beckman Coulter, Inc..
[280470]
The customer complaint states that the datalink data manager combined archived tests results from different patients when an archived result was printed. Field service personnel could not duplicate the event described. No treatment has been affected by this event, however when results from one patient are added to a different patient's report, the potential exists for inappropriate treatment to be initiated. Since the beckman coulter datalink system can not be positively ruled out as a contributor to this event, beckman coulter believes this event meets the reporting criteria of 21 cfr 803.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2002-00004 |
| MDR Report Key | 385741 |
| Report Source | 05,06 |
| Date Received | 2002-03-26 |
| Date of Report | 2002-03-22 |
| Date of Event | 2002-02-26 |
| Date Mfgr Received | 2002-02-26 |
| Date Added to Maude | 2002-04-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | REGINA O'MEARA |
| Manufacturer Street | 200 S. KRAEMER BLVD PO BOX 8000, MAIL STOP W-561 |
| Manufacturer City | BREA CA 926228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 926228000 |
| Manufacturer Phone | 7149614489 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DATALINK |
| Generic Name | DATA MANAGEMENT SYSTEM |
| Product Code | JOP |
| Date Received | 2002-03-26 |
| Model Number | DATALINK |
| Catalog Number | 464800 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 374788 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 200 S. KRAEMER BLVD. BREA CA 92822 US |
| Baseline Brand Name | DATALINK |
| Baseline Generic Name | DATA MGMT SYSTEM |
| Baseline Model No | DATALINK |
| Baseline Catalog No | 464800 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-26 |