MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-09-21 for ACCESS CK-MB REAGENT 386371 manufactured by Beckman Coulter.
[26479785]
The customer did not provide patient demographics, such as age or weight. The customer provided the patient was born in 1989. The customer performed hardware verification to include obtaining a passing access ck-mb precision run and system check. A beckman coulter (bec) field service engineer (fse) verified operation of the instrument by performing a passing access ck-mb precision run. The fse did not note any hardware malfunctions. The access ck-mb reagent was not returned for evaluation. The cause of the non-reproducible accessck-mb results cannot be determined with the available information.
Patient Sequence No: 1, Text Type: N, H10
[26479786]
The customer noted non-reproducible creatine kinase-muscle brain isoform (access ck-mb) patient results for one (1) female patient. The customer repeat tested the sample several times on the same unicel dxi 600 access immunoassay system and obtained erratic results. The customer repeat tested the sample on an alternate unicel dxi 600 access immunoassay system (serial number (b)(4)) and obtained lower results, within the normal reference range of the assay. The customer obtained a second sample from the patient and tested the sample on the alternate unicel dxi 600 access immunoassay system (serial number (b)(4)) and obtained lower results, within the normal reference range of the assay. There was no report of patient injury or change in patient treatment associated with this event. All system parameters (including quality control (qc), access ck-mb calibration, access ck-mb precision run and system check) were within assay and instrument specifications. Samples are collected in lithium heparin gel separator tubes. Samples are centrifuged at 2600 relative centrifugal force (rcf) for ten (10) minutes at room temperature the customer did not note any issues with sample integrity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2015-00594 |
| MDR Report Key | 5091837 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-21 |
| Date of Report | 2015-08-29 |
| Date of Event | 2015-08-29 |
| Date Mfgr Received | 2015-08-29 |
| Device Manufacturer Date | 2015-05-27 |
| Date Added to Maude | 2015-09-21 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 2015-09-21 |
| Model Number | NA |
| Catalog Number | 386371 |
| Lot Number | 527148 |
| Device Expiration Date | 2016-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2015-09-21 |