MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-30 for ACCESS CK-MB REAGENT. 386371 manufactured by Beckman Coulter.
[5619028]
The customer reported a non-reproducible, falsely elevated creatine kinase mb (access ck-mb) result for one (1) patient on the unicel dxi 600 access immunoassay system (serial number (b)(4)). The customer reanalyzed the patient sample on the same unicel dxi 600 access immunoassay system and obtained results that were within the normal reference range of the assay. The customer stated that the non-reproducible access ck-mb result was reported outside the laboratory. There was a change to patient treatment reported as the patient was started on heparin in association with the falsely elevated access ck-mb result obtained. The customer noted quality control (qc) was within the laboratory's established ranges prior to and after the event. The system check was within instrument specifications. The patient sample was collected in a lithium heparin tube. Sample processing information such as centrifugation speed and time were not provided. A beckman coulter field service engineer (fse) was dispatched to assess the instrument's performance.
Patient Sequence No: 1, Text Type: D, B5
[13057374]
The customer did not provide patient demographics such as age, date of birth, sex or weight. The access ck-mb reagent was not returned for evaluation. A beckman coulter field service engineer (fse) was dispatched to evaluate the instrument's performance. The fse evaluated the instrument and performed repairs unrelated to this event. All verification testing passed within specifications. In conclusion, the cause of the event cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2015-00181 |
| MDR Report Key | 4640967 |
| Report Source | 05,06 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-12 |
| Date of Event | 2015-03-09 |
| Date Mfgr Received | 2015-03-12 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-03-30 |
| 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 |
| 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 REAGENT. |
| Generic Name | FLUOROMETRIC METHOD, CPK OR ISOENZYMES |
| Product Code | JHX |
| Date Received | 2015-03-30 |
| Model Number | NA |
| Catalog Number | 386371 |
| Lot Number | 428051 |
| Device Expiration Date | 2015-06-30 |
| 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. Other | 2015-03-30 |