MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-25 for ACCESS? 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter.
[20717593]
The customer reported erroneously elevated creatine kinase-mb (ck-mb) result, above the normal reference range, for one patient, involving the access 2 immunoassay system. The erroneous result was released out of the laboratory and questioned by the physician as the value did not correlate with the patient's clinical presentation. The customer reanalyzed the sample on the same instrument and recovered a lower result within the normal reference range. A new sample was collected from the patient two hours after, analyzed on an alternate instrument, and produced a lower result, within the normal reference range. There was no patient injury or change in patient treatment associated with this event. The patient's samples were collected in 3 ml becton dickinson lithium heparin tubes with no serum separator and centrifuged between 3,000-5,000 rpm (rotations per minute) for five minutes. The samples were normal in appearance. No quality control (qc) issues were noted. A beckman coulter field service engineer (fse) was dispatched to assess the instrument.
Patient Sequence No: 1, Text Type: D, B5
[21111129]
The field service engineer (fse) noted a loud noise coming from the vacuum pump. When the fse attempted to back-flush the vacuum pump, liquid escaped from the pump. The fse replaced the vacuum pump and peristaltic pump tubing. The fse performed high sensitivity inc52 and high sensitivity lwson tests which failed on the hsson portion. The fse replaced the aspirate probes and retested the hsson portion which passed within the acceptable range. 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. In conclusion, the likely cause of the erroneous ck-mb result was the vacuum pump.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00638 |
| MDR Report Key | 3248463 |
| Report Source | 05,06 |
| Date Received | 2013-07-25 |
| Date of Report | 2013-07-03 |
| Date of Event | 2013-07-03 |
| Date Mfgr Received | 2013-07-03 |
| Device Manufacturer Date | 2001-07-05 |
| Date Added to Maude | 2013-10-22 |
| 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 | JHS |
| Date Received | 2013-07-25 |
| 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 | 2013-07-25 |