MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-03-13 for BECKMAN COULTER ACCESS IMMUNOASSAY SYSTEM ACCESS INSTRUMENT MYOGLOBIN 81500 manufactured by Beckman Coulter, Inc..
[271332]
Customer states that a myoglobin reagent pack, with 10 tests remaining, was loaded on an access instrument and 10 tests were run. The first two results were acceptable and the remaining 8 test results were all 0. 0 with no system flags. Two of the 0. 0 results were reported. Repeat testing of the 0. 0 samples produced normal results. No treatment was initiated or witheld based on these results. Investigation determined that the myoglobin pack was used previously on a different access system and was moved to the access system in question where the 0. 0 results were produced. Product labeling clearly states that access reagent packs cannot be removed and used on a different system. The second instrument assumes a full reagent cartridge has been loaded and when the cartridge has already been used on a different instrument, the reagent volume will be less that assumed. This is a user error, in that, failure to follow instructions resulted in the incorrect result. A potential health risk to the patient does exist when a false 0. 0 myoglobin result is reported. A 0. 0 myoglobin result could be used by a physician in the course of patient care, and has the potential to affect the diagnosis or modify a course of treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2002-00003 |
| MDR Report Key | 383279 |
| Report Source | 05,06 |
| Date Received | 2002-03-13 |
| Date of Report | 2002-03-08 |
| Date of Event | 2002-02-10 |
| Date Mfgr Received | 2002-02-11 |
| Date Added to Maude | 2002-03-22 |
| 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 Street | 200 S. KRAEMER BLVD P.O. 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 | DDR |
| Date Received | 2002-03-13 |
| Model Number | ACCESS INSTRUMENT MYOGLOBIN |
| 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 | 372348 |
| 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 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-13 |