MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-05 for ACCESS? 2 IMMUNOASSAY ANALYZER 81600N manufactured by Beckman Coulter.
[3327248]
A customer contacted beckman coulter (bec) reporting two (2) erroneous creatinine kinase - mb (ck-mb) patient results that were generated on the access 2 immunoassay analyzer on two (2) different patients. The customer stated the ck-mb results initially recovered low; however, upon repeat, on another instrument, produced higher results. The customer declined to provide the actual result data. Therefore, a worst case scenario will be assumed, with the initial result recovering within the normal reference range and the repeat result recovering above the normal reference range. The customer stated the erroneous results were not reported outside the laboratory. The customer did not report affect to patients or users attributed or connected to this event. The customer also reported "mixer speed outside limits" error messages posted to their event log from around the time of the event. This would indicate the mixer speed was either below 1,500 rpm or above 3,000 rpm (nominal is 2,500 rpm). Bec customer technical support (cts) had the customer visually inspect the mixer belt, and the customer confirmed the belt was intact and moving. The customer reported a mixer speed of 2,440 rpm clockwise and 2,490 rpm counterclockwise (specification is 2,500? 20 rpm). A service request was initiated to inspect the instrument.
Patient Sequence No: 1, Text Type: D, B5
[10611517]
The customer utilizes 13x100 mm lithium heparin plasma separator tubes for sample collections, and centrifuges samples for 5 minutes (the customer declined to provide centrifugation speed). The customer declined to provide the brand. The customer did not report any sample quality issues. The customer declined to provide event-specific qc data. The customer stated qc was within the laboratory's established limits on the event date. No other assays or patient results are in question. A bec field service engineer (fse) was dispatched and found the mixer belt tensioner assembly (p/n 7904a) not moving freely and replaced it. The fse also replaced the mixer motor (p/n 6943a). In conclusion, the likely cause for this event is hardware malfunction; specifically, premature failure of the mixer belt tensioner assembly (p/n 7904a).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2013-00342 |
| MDR Report Key | 3039305 |
| Report Source | 05,06 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-03-08 |
| Date of Event | 2013-03-08 |
| Date Mfgr Received | 2013-03-08 |
| Device Manufacturer Date | 2002-02-18 |
| Date Added to Maude | 2013-06-04 |
| 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 |
| 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 BOULEVARD |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS? 2 IMMUNOASSAY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JLB |
| Date Received | 2013-04-05 |
| Model Number | ACCESS? 2 |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-05 |