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 2015-09-25 for ACCESS CK-MB REAGENT 386371 manufactured by Beckman Coulter.
[26824012]
The customer did not provide patient weight. A beckman coulter (bec) field service engineer (fse) was dispatched to assess instrument performance. The fse proactively performed preventative maintenance on the access 2 immunoassay system. The fse did not note any system malfunction that would have contributed to the reported event. The access ck-mb reagent pack was not returned for evaluation. In conclusion, the cause of the non-reproducible access accutni+3 and access ck-mb results cannot be determined with the available information. (b)(4). All mdrs associated with this report: mdr2122870-2015-00618; mdr2122870-2015-00619.
Patient Sequence No: 1, Text Type: N, H10
[26824013]
The customer reported non-reproducible troponin i (access accutni+3) and creatine kinase-muscle brain isoform (access ck-mb) results for one (1) patient on the access 2 immunoassay system (serial number (b)(4)). The customer runs all access accutni+3 samples in duplicate. It was noted both of the initial access accutni+3 results were elevated, above the normal reference range of the assay. The customer repeat tested the samples on the same access 2 immunoassay system and obtained lower results, within the normal reference range of the assays. Mdr2122870-2015-00618 addresses the access accutni+3 results. Mdr2122870-2015-00619 addresses the access ck-mb results. The initial elevated results were reported outside the laboratory and the patient was admitted to the hospital. All system parameters including access accutni+3 and access ck-mb quality control (qc), access accutni+3 and access ck-mb calibrations and system check were within assay specifications and instrument specifications. Sample information such as collection device, centrifugation speed and time were not provided. No issues with sample integrity were reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2122870-2015-00619 |
| MDR Report Key | 5105312 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-25 |
| Date of Report | 2015-09-10 |
| Date of Event | 2015-09-10 |
| Date Mfgr Received | 2015-09-10 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-09-25 |
| 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 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 | 2015-09-25 |
| Model Number | NA |
| Catalog Number | 386371 |
| Lot Number | 437908 |
| Device Expiration Date | 2016-02-28 |
| 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 | 1. Hospitalization | 2015-09-25 |