MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-05 for ACCESS? 2 IMMUNOASSAY ANALYZER 81600N manufactured by Beckman Coulter.
[3639533]
The customer reported obtaining erroneously low creatinine kinase (access ck-mb) results of 0. 00 ng/ml, for two (2) patient samples, involving the access 2 immunoassay analyzer. Subsequent repeat of the samples on the same instrument produced higher ck-mb results which better matched the expected value for the patients. The customer stated that the results were not released out of the laboratory until all repeat testing were completed. There was no change or affect to patient treatment in connection with this event. All system parameters, including calibrations, quality control results, and system checks were performing within the assay/instrument specifications prior to the event. The customer confirmed that the instrument did not generate any error messages at the time of the event. The samples were sodium-heparinized plasma samples which were centrifuged at 3500 rpm for ten minutes. The samples were collected in 4 ml tubes and sampled from the primary tube on the instrument. The customer did not re-centrifuge the samples prior to repeat testing. Troponin was also run on these samples and the results were reproducible.
Patient Sequence No: 1, Text Type: D, B5
[10978049]
A beckman coulter field service engineer (fse) was dispatched to the customer's site. The fse found the pipettor to be dirty and proceeded to replace the pipettor. The fse also discovered that the ultrasonics voltage to be out of specifications and proceeded to adjust the voltage to within instrument specifications. Repair was verified per established procedures and results met published specifications. Failure mode is likely attributed to hardware/system malfunction leading to the ultrasonics voltage being out of instrument specification; the fse adjusted the voltage to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00685 |
| MDR Report Key | 3263011 |
| Report Source | 05,06 |
| Date Received | 2013-08-05 |
| Date of Report | 2013-07-15 |
| Date of Event | 2013-07-14 |
| Date Mfgr Received | 2013-07-15 |
| Device Manufacturer Date | 2008-07-14 |
| Date Added to Maude | 2013-10-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| 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 ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-08-05 |
| 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 |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-05 |