MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-27 for ACCESS? 2 IMMUNOASSAY SYSTEM ACCESS 2 81600N manufactured by Beckman Coulter, Inc..
[2219768]
A customer reported to beckman coulter, inc. (bec) that access 2 immunoassay system generated erroneously elevated ckmb results, above the normal reference range, on two patient samples. The erroneous results were not reported out of the laboratory. Repeat testing on an alternate instrument produced results within the normal reference range. The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed or connected to this event.
Patient Sequence No: 1, Text Type: D, B5
[9372569]
The patient samples were collected in serum tubes, and were centrifuged for 5 minutes at 5607 rpm. The samples were not re-centrifuged prior to repeat testing. Qc was performing within the established limits on the date of the event. A system check performed by the customer on (b)(4) 2011 passed within the instrument specifications. The customer reported there was a wash valve/pump motion error message in the instrument event log. Service was on site on the date of the event, (b)(6) 2011. The field service engineer (fse) discovered a crack in the wash pump home sensor. The fse replaced the wash pump home sensor and reseated the wash pump flag. The fse performed a 20 replicate low level accutni precision run with acceptable but slightly erratic results. The fse observed build up on the transducer and after cleaning the transducer and performing a second precision run with questionable results, the fse ordered a replacement transducer for installation at a later date. The fse returned to the customer site on (b)(4) 2011, and replaced the transducer. The fse performed a precision run to verify hardware. The accutni precision runs using low level and high level accutni qc both produced results within the established qc ranges and within the published assay precision claims. Although hardware repairs were required at the time of service, a definitive root cause for this event has not been determined to date. The related events are reported in the below listed medwatch reports: 2122870-2011-04743, 2122870-2011-04733, 2122870-2011-05007.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-05005 |
| MDR Report Key | 2311945 |
| Report Source | 05,06 |
| Date Received | 2011-10-27 |
| Date of Report | 2011-09-28 |
| Date of Event | 2011-09-27 |
| Date Mfgr Received | 2011-09-28 |
| Device Manufacturer Date | 2007-08-29 |
| Date Added to Maude | 2011-11-02 |
| 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 | 0 |
| 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, INC. |
| 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 SYSTEM |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | JHS |
| Date Received | 2011-10-27 |
| Model Number | ACCESS 2 |
| Catalog Number | 81600N |
| Lot Number | NA |
| ID Number | SW 3.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-27 |