MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-10-27 for ACCESS CK-MB 386371 manufactured by Beckman Coulter.
[58613380]
A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer. The fse requested the customer to perform a special clean and re-ran controls several times. The fse also performed a precision test and assessed system performance. No additional information or issues were reported; therefore, there is insufficient evidence of a hardware or system malfunction. The assignable cause of this event is unknown and cannot be determined with the information provided. All mdrs associated with this event: 2122870-2016-00507, 2122870-2016-00508.
Patient Sequence No: 1, Text Type: N, H10
[58613381]
The customer reported obtaining a non-reproducible creatine kinase, isoenzyme mb (access ck-mb) results generated from the laboratory's unicel dxi 800 access immunoassay system serial number (b)(4) for a patient sample. On (b)(6) 2016, an elevated access ck-mb result of 46. 848 ng/ml was generated. The same sample was repeated and lower results of 2. 456 ng/ml and 2. 046 ng/ml were obtained. The results were not reported outside of the laboratory. There were no reports of patient injuries or change to patient treatment associated with this event. Mdr 2122870-2016-00507 will address the troponin i (access accutni+3) results obtained on (b)(6) 2016 for this same patient. System parameters including quality controls (qcs) and system checks were recovering within assay and system parameters. Calibration data was not provided for review. The samples were collected in a 13x100 mm lithium heparin tube that was centrifuged at 3000 revolutions per minute (rpm) for 5 minutes at room temperature. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer's performance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2016-00508 |
| MDR Report Key | 6060677 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-10-02 |
| Date Mfgr Received | 2016-10-03 |
| Device Manufacturer Date | 2016-04-25 |
| Date Added to Maude | 2016-10-27 |
| 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 | MS. ANGELA KILIAN |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681330 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 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 |
| Product Code | JHX |
| Date Received | 2016-10-27 |
| Model Number | NA |
| Catalog Number | 386371 |
| Lot Number | 622968 |
| Device Expiration Date | 2017-04-30 |
| 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 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-27 |