MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-01 for ACCESS? 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2737348]
Customer reported to beckman coulter, inc. (bec) that the access 2 immunoassay system (access 2), generated an erroneous ck-mb result for an emergency room patient. Customer reported that the erroneous result was reported out of the laboratory. Customer reported that the erroneous result was corrected. There was no report of any adverse event or injury requiring medical intervention or patient treatment. Customer reported that for the past few weeks, the washed portion of the system check failed the first time the instrument was ran and then the system check passed upon repeat. Customer reported that access ck-mb reagent, lot 123056, and access ck-mb calibrator, lot 119344, were used in conjunction with the access 2 system. Bec field service engineer (fse), noted a few bubbles in the pipettor line. The fse proactively rebuilt the precision and wash pumps. The fse also verified alignments and ultrasonics. No issues were noted.
Patient Sequence No: 1, Text Type: D, B5
[10089329]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01641 |
| MDR Report Key | 2678276 |
| Report Source | 05,06 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-07-07 |
| Date of Event | 2012-07-07 |
| Date Mfgr Received | 2012-07-07 |
| Device Manufacturer Date | 2004-11-04 |
| Date Added to Maude | 2012-11-23 |
| 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 BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 |
| 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 | 2012-08-01 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| ID Number | S W VERSION 2.8 |
| 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 | 250 S. KRAEMER BOULEVARD BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-01 |