MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-08 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[21424866]
Customer reported erroneous test results were obtained when using an access 2 immunoassay system. Four patient samples were tested for vitamin b12 and free t4 and erroneous elevated test results were obtained. An instrument message did occur with two of the four tests. All tests were repeated, and were within the normal reference range. No erroneous test results were reported. No reports of death or serious injury, and no affect to patient treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[21519913]
Quality control (qc) was within specifications before and after this event. Once the erroneous results were discovered the operator ran a diagnostic system check which was within specifications. H3: field service engineer (fse) evaluated the analyzer (b)(4) 2008. The pipettor was loose, the mixer speed was out of specification low, and the precision pump mounting screw was disconnected. The fse adjusted the ultrasonics and replaced the precision pump belt. A precision run and quality control met specifications. The fse verified repair per established procedures. Results met published specifications. Root cause was not determined. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 and (b)(4) 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01137 |
| MDR Report Key | 2183542 |
| Report Source | 05,06 |
| Date Received | 2011-07-08 |
| Date of Report | 2008-09-19 |
| Date of Event | 2008-09-18 |
| Date Mfgr Received | 2008-09-19 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2012-05-01 |
| 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. NORA ZEROUNIAN |
| 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 DR. |
| 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 |
| Product Code | CGN |
| Date Received | 2011-07-08 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DR. CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-08 |