MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-13 for ACCESS? 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[15758736]
The customer reported a lower than expected creatine kinase-mb (ck-mb) result, for one patient, involving the access 2 immunoassay system. Subsequent analysis of the patient sample, on the same analyzer, recovered a higher result, within the normal reference range. The erroneous result was not released out of the laboratory. There was no patient impact associated with this event. Beckman coulter field service engineer (fse) was dispatched to evaluate the instrument.
Patient Sequence No: 1, Text Type: D, B5
[15867182]
The field service engineer (fse) discovered the main pipettor tip was bent. The fse replaced the pipettor tip and wash station insert, performed alignments and verified the ultrasonics. The fse replaced the incubator belt due to noise. A routine system check was performed which passed within instrument specifications. Quality control (qc) passed within the laboratory's established ranges. The instrument conformed to the manufacturer's published performance specifications. Patient samples were collected in 6 ml becton dickinson (bd) primary tubes. Prior to analysis, samples are aliquoted into an insert tube. Samples are centrifuged at 5,600 rpm (revolutions per minute) for five minutes in a stat spin centrifuge. Emergency room samples are typically processed within the hour; outpatient samples are processed within 1-2 hours from collection. System check, performed on (b)(6) 2012, passed within specifications. This medwatch report is related to mdr 2122870-2012-01902.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01910 |
| MDR Report Key | 2830938 |
| Report Source | 05,06 |
| Date Received | 2012-11-13 |
| Date of Report | 2012-10-18 |
| Date of Event | 2012-10-17 |
| Date Mfgr Received | 2012-10-18 |
| Device Manufacturer Date | 2005-12-14 |
| Date Added to Maude | 2013-02-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? 2 IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2012-11-13 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-13 |