MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-06 for ACCESS CK-MB 386371 manufactured by Beckman Coulter.
[4768360]
The customer reported non-reproducible creatine kinase-mb (ck-mb) results, for two patients, involving the access ck-mb assay used in conjunction with the unicel dxi 600 access immunoassay system. The customer stated the initial questioned results were reported out of the laboratory. The customer was not aware of any impact to patient care. There has been no report of patient injury or change in patient treatment associated with this incident. Subsequent testing of the patients' samples, on an alternate unicel dxi 600 system, generated varied results. The patients' samples were collected in 13x100 mm becton dickinson lithium heparin tubes and centrifuged at 4,000 rpm (rotations per minute) for ten minutes, in ambient temperature. The samples were stored in refrigeration prior to reanalysis. The customer noted a slight cloudiness in the samples but did not observe any sample integrity issues. The customer indicated quality control recovered outside the laboratory's established limits on the original instrument. The customer then completed a 30-replicate precision assessment on the original instrument and a 27-replicate precision assessment on the alternate instrument. The calculated precision was within the expected total imprecision of the ck-mb assay for both instruments. No system issues were reported. The instrument was in operation.
Patient Sequence No: 1, Text Type: D, B5
[12245780]
There is no indication that the access ck-mb device was returned for evaluation. Service was not dispatched as the customer did not question system performance. In conclusion, a definitive cause of the incident could not be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2014-00704 |
| MDR Report Key | 4146051 |
| Report Source | 05,06 |
| Date Received | 2014-10-06 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-09-16 |
| Date Mfgr Received | 2014-09-16 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-10-16 |
| 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 |
| 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 CK-MB |
| Generic Name | FLUOROMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHX |
| Date Received | 2014-10-06 |
| Model Number | NA |
| Catalog Number | 386371 |
| Lot Number | 426666 |
| ID Number | NA |
| Device Expiration Date | 2015-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-10-06 |