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..
[20395403]
A system check was performed on (b)(4) 2009 at 09:40, passed within specifications. Quality control (qc) levels 1 and 2 were out of specification high at 11:40, prior to the erroneous results. The customer repeated the qc and it was still out of specification high. Customer was advised by customer support hotline to perform weekly maintenance, recalibrate and repeat qc the morning of (b)(4) 2009. All three levels of qc were within specifications after maintenance and recalibrating. Customer then repeated patient samples and still observed precision issues with b12. Customer noted precision issues with other b12 patient samples also. The four patient samples, were the only samples that resulted in different clinical categories. Customer only has one access system instrument which would rule out pack sharing. Field service engineer performed hardware verification testing and all met published performance specifications. No deficiencies were identified. Root cause is unknown. 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
[20411168]
Customer reported erroneous vitamin b12 test results were obtained when using an access 2 immunoassay system. Erroneous test results were reported out of the laboratory. 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
| Report Number | 2122870-2011-02166 |
| MDR Report Key | 2183585 |
| Report Source | 05,06 |
| Date Received | 2011-07-08 |
| Date of Report | 2009-02-17 |
| Date of Event | 2009-02-17 |
| Date Mfgr Received | 2009-02-18 |
| Device Manufacturer Date | 2004-10-01 |
| 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 |