MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-12-21 for CREATININE KINASE (CK-MB) OSR61155 manufactured by Beckman Coulter.
[5142914]
The customer reported obtaining erratic creatinine kinase-mb (ck-mb) patient results and quality control recoveries from the au680 clinical chemistry analyzer. The customer stated that the results obtained from the au680 clinical chemistry analyzer were discrepant to two alternate analyzers. The customer did not provide any comparative data and the discrepancy between methods could not be confirmed. The erroneous patient results were not released out of the laboratory and there was no report of any change or affect to patient treatment in connection with this event. The customer stated that the au680 clinical chemistry analyzer had been inactive for one year and the customer encountered issues with the ck-mb assay (non-reproducible results) upon instrument reactivation. The customer stated that all other assays and patient results were comparable with the alternate system in the laboratory. The customer stated that the issue only affects ck-mb results. The creatinine kinase-mb (ck-mb) reagent was used in conjunction with the au680 clinical chemistry analyzer serial number (b)(4) for this event.
Patient Sequence No: 1, Text Type: D, B5
[12701076]
The customer did not provide any patient demographics information the initial reporter's country is (b)(6) and the telephone number is (b)(6). Applications specialists were dispatched to the customer's site to evaluate the event. The application specialists analyzed the ck-mb reagent on alternate au analyzers and the reagent performed within specifications. It is unknown if the same reagent cartridge was evaluated on the alternate au system or if it was a different cartridge of the same lot. The customer provided data for analysis and a review of the data suggests an issue with the r2 reagent dispense, indicating possible bubbles in the reagent but insufficient to conclude a failure. Reaction monitors were also provided and a review indicates atypical reaction kinetics. The customer observed similar phenomenon on the quality control (qc) data and none of the patient results generated were reported out of the laboratory. In conclusion, the cause of the event cannot be determined; however, based on the abnormal reaction monitors and erratic ck-mb qc recovery, there is evidence of reagent-specific malfunction that solely affects the ck-mb assay on this analyzer. There is no indication that the ck-mb reagent in question was returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680746-2014-00002 |
| MDR Report Key | 4349017 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-21 |
| Date of Report | 2014-11-24 |
| Date of Event | 2014-11-15 |
| Date Mfgr Received | 2014-11-24 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2015-01-07 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER IRELAND |
| Manufacturer Street | LISMEEHAN |
| Manufacturer City | O'CALLAGHAN'S MILLS, COUNTY CLARE |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CREATININE KINASE (CK-MB) |
| Generic Name | COLORIMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHY |
| Date Received | 2014-12-21 |
| Model Number | NA |
| Catalog Number | OSR61155 |
| Lot Number | 5697 |
| ID Number | NA |
| Device Expiration Date | 2015-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-12-21 |