MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-31 for ACCESS? 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter.
[3618343]
The customer reported erroneously low creatine kinase-mb (ck-mb) results, for one patient, involving the access 2 immunoassay system. Subsequent testing of the patient? S sample, on the same instrument, recovered higher results that better matched the patient? S expected value. The erroneous results were not released out of the laboratory. There was no report of patient consequence or change in patient treatment associated with this event. The patient? S samples were collected in sodium heparin plasma tube and centrifuged at 3,500 rpm (rotations per minute) for ten minutes. The laboratory? S policy is to perform quality control (qc) every 24 hours and retest both critical samples and samples with 0. 00 recovery. All levels of qc recovered within the laboratory? S established ranges prior to and following the event. All level of calibrators passed within the acceptable percent coefficient of variation (%cv). System check passed within instrument specifications. A beckman coulter field service engineer (fse) was dispatched to assess the instrument.
Patient Sequence No: 1, Text Type: D, B5
[10915704]
The field service engineer (fse) primed the system and noted bubbles within the wash pump and rebuilt the wash pump to resolve the bubble issue. The fse noted the aspirate probes were dirty and rust on the probes and replaced the probes. The fse replaced the substrate probe as the tip was bent. The fse replaced the peristaltic pump tubing as it was slightly flattened. The mixer belt was replaced as it was worn. The fse cleaned the wash pump, precision pump, dispense probes, and sample pipettor. System verification testing (priming, alignment verification, volume tests, ultrasonics testing, system check, high sensitivity system check, 10-point precision testing, and quality control) was within specifications. Service activity performed was verified to meet the specified requirements per established procedures. The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00660 |
| MDR Report Key | 3257731 |
| Report Source | 05,06 |
| Date Received | 2013-07-31 |
| Date of Report | 2013-07-10 |
| Date of Event | 2013-07-10 |
| Date Mfgr Received | 2013-07-10 |
| Device Manufacturer Date | 2008-07-14 |
| Date Added to Maude | 2013-10-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? 2 IMMUNOASSAY SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-07-31 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-31 |