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 2015-08-14 for ACCESS CK-MB REAGENT 386371 manufactured by Beckman Coulter.
[23425974]
The customer did not provide patient demographics such as age, date of birth, sex or weight. The customer performed a passing system check and fifteen (15) replicate precision run for access accutni+3 and access ck-mb. A beckman coulter (bec) field service engineer (fse) was dispatched to verify instrument performance. The fse made proactive repairs to include replacing the substrate probe, aspirate probes and associated peri-pump tubing and dispense probes. The fse proactively cleaned the wash pump valve and replaced the seals. 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. Mdrs associated with this report: mdr2122870-2015-00496; mdr2122870-2015-00497. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23425975]
The customer stated they noted non-reproducible troponin i (access accutni+3) and creatine kinase-muscle brain isoform (access ck-mb) results for one (1) patient on the laboratory's access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system ( serial number (b)(4)). The customer repeat tested the sample several times on the same access 2 immunoassay system portion of the unicel dxc 600i synchron access clinical system and obtained lower results, within the normal reference range of the assays. The customer also noted the patient had two subsequent draws that yielded access accutni+3 and access ck-mb results within the normal reference range of the assays. This report addresses the non-reproducible access ck-mb results obtained on (b)(6) 2015. Mdr 2122870-2015-00496 addresses the non-reproducible access accutni+3 results obtained on (b)(6) 2015. The customer stated the elevated access accutni+3 and access ck-mb results were released from the laboratory. The patient was given aspirin. There was no report of additional patient injury or change in patient treatment associated with this event. All system parameters (including quality control (qc), access accutni+3 and access ck-mb calibration, access accutni+3 and access ck-mb precision run and system check) were within assay and instrument specifications. Samples are collected in lithium heparin plasma gel separator tubes and centrifuged at 4500 revolutions per minute (rpm) for three (3) minutes. The customer did not note any issues with sample integrity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2015-00497 |
| MDR Report Key | 5005606 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-08-14 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-07-21 |
| Date Mfgr Received | 2015-07-21 |
| Device Manufacturer Date | 2015-05-27 |
| Date Added to Maude | 2015-08-14 |
| 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 | 2015-08-14 |
| 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 | 2015-08-14 |