MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-19 for ACCESS CK-MB REAGENT 386371 manufactured by Beckman Coulter.
[22026292]
The customer reported obtaining a non-reproducible creatine kinase m sub-unit/b sub-unit (access ck-mb) result involving the unicel dxi 800 access immunoassay system serial number (b)(4) for one (1) patient. The patient's sample was reanalyzed on the same unicel dxi 800 access immunoassay system and a lower result, within the laboratory's normal reference range, was obtained. The elevated access ck-mb result was released from the laboratory. There was a report of a change in patient treatment as the customer stated that the patient was admitted to the hospital in association with the elevated access ck-mb result. Quality control (qc), calibration, precision, and system check were performing within assay and instrument specifications at the time of the event. The sample was serum, collected in a serum separator gel tube. The sample was centrifuged on the automation line for six (6) minutes at 30,000 rpm (revolutions per minute). The customer indicated the sample contained fibrin.
Patient Sequence No: 1, Text Type: D, B5
[22349248]
There is no indication the access ck-mb reagent was returned for evaluation. A beckman coulter (bec) field service engineer (fse) was not dispatched. System parameters of quality control (qc), calibration, precision, and system check were performing within assay and instrument specifications. In conclusion, the cause of the event was pre-analytical sample handling as the sample contained fibrin. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2015-00358 |
| MDR Report Key | 4856156 |
| Report Source | 05,06 |
| Date Received | 2015-06-19 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-05-29 |
| Date Mfgr Received | 2015-06-02 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-06-19 |
| 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 | MR. JEFFREY KOLL |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681361 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS CK-MB REAGENT |
| Generic Name | FLUOROMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHX |
| Date Received | 2015-06-19 |
| Model Number | NA |
| Catalog Number | 386371 |
| Lot Number | 437908 |
| Device Expiration Date | 2016-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-06-19 |