MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-26 for ACCESS CK-MB 386371 manufactured by Beckman Coulter.
[5829724]
The customer reported non-reproducible creatine kinase mb (access ck-mb) results for one (1) patient on the laboratory's access 2 immunoassay system (serial number (b)(4)). The customer stated they run all access ck-mb samples in duplicate. After noting the non-reproducible access ck-mb result, the customer repeat tested the patient sample on the same access 2 immunoassay system and obtained a result above the assay's normal reference range. The customer stated the initial lower access ck-mb result was not released from the lab. There was no report of patient injury or change in patient treatment associated with this event. All system parameters (including quality control (qc), calibration and system check) were within assay and instrument specifications. Samples are collected in lithium heparin plasma tubes and centrifuged at 5000 revolutions per minute (rpm) for two (2) minutes. The customer did not note any issues with sample integrity.
Patient Sequence No: 1, Text Type: D, B5
[13335719]
The customer performed a passing system check. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer's performance. The fse made incidental repairs. No hardware or system issues were identified as contributing to the reported event. The access ck-mb reagent was not returned for evaluation. The cause of the reported event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2015-00302 |
| MDR Report Key | 4796319 |
| Report Source | 05,06 |
| Date Received | 2015-05-26 |
| Date of Report | 2015-05-02 |
| Date of Event | 2015-04-30 |
| Date Mfgr Received | 2015-05-02 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-06-23 |
| 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. JEFFERY KOLL |
| Manufacturer Street | 1000LAKE HAZEKTINE 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 |
| Generic Name | FLUOROMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHX |
| Date Received | 2015-05-26 |
| Model Number | NA |
| Catalog Number | 386371 |
| Lot Number | 430005 |
| Device Expiration Date | 2015-08-31 |
| 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 | 2015-05-26 |