MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-04-09 for BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEM ACCESS INSTRUMENT CK-MB 81500 manufactured by Beckman Coulter, Inc..
[230540]
Customer states that false low ck-mb results were produced and reported from the access instrument using the ck-mb reagent. Each low result was properly flagged with a unr message by the instrument. Operator did not know what a unr flag meant and reported the results. This event and unr flags originated from the initial user error, which was moving the reagent pack from one instrument to another instrument. This is specifically prohibited in the labeling. While there are multiple user errors involved, the resulting false low ck-mb results could be used by a physician and may contribute to a delayed diagnosis and the potential for serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2002-00005 |
| MDR Report Key | 388661 |
| Report Source | 05,06 |
| Date Received | 2002-04-09 |
| Date of Report | 2002-03-28 |
| Date of Event | 2002-02-26 |
| Date Mfgr Received | 2002-02-26 |
| Date Added to Maude | 2002-04-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SHERI HALL |
| Manufacturer Street | 200 S. KRAEMER BLVD PO BOX 8000, MAIL STOP W-104 |
| Manufacturer City | BREA CA 926228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 926228000 |
| Manufacturer Phone | 7149938916 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEM |
| Generic Name | CLINICAL IMMUNOASSAY ANALYZER |
| Product Code | JHY |
| Date Received | 2002-04-09 |
| Model Number | ACCESS INSTRUMENT CK-MB |
| Catalog Number | 81500 |
| 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 | 377708 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US |
| Baseline Brand Name | BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEM |
| Baseline Generic Name | CLINICAL IMMUNOASSAY ANALYZER |
| Baseline Model No | ACCESS INSTRUME |
| Baseline Catalog No | 81500/33300 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-09 |