MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-05-26 for ACCESS 2 IMMUNOASSAY SYSTEM 81600N manufactured by Beckman Coulter, Inc..
[2073245]
The customer contacted beckman coulter, inc. (bci) on (b)(6) 2008, in regards to elevated accutni results generated on the access 2 immunoassay system for 4 patients on different days. The initial elevated results were reported outside the laboratory. The patient samples were retested on a different system and the results were within the normal reference range. The corrected results were then reported. There are no reports of any adverse patient consequence or change to the patients' treatment. There are no indications of any medical intervention to prevent or preclude any adverse patient event. This report refers to patient number four.
Patient Sequence No: 1, Text Type: D, B5
[9170116]
Service was not dispatched for this event. Quality control (qc) data was reviewed and it was within specification. No definitive root cause could be determined for this event. Service was not dispatched for this event. The quality control (qc) data was provided by the customer and reviewed. The data shows that the qc was within specification. No definitive root cause could be determined for this event. This is four of four separate mdr reports related to four patient events associated with a single malfunction report on different days. Reference mdr numbers: 2122870-2011-01603, 2122870-2011-01604, 2122870-2011-01605 for all events. This reportable event was identified during a retrospective review of complaints conducted between (b)(4) 2008 and (b)(4) 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01606 |
| MDR Report Key | 2145126 |
| Report Source | 01,05,06 |
| Date Received | 2011-05-26 |
| Date of Report | 2008-12-11 |
| Date of Event | 2008-12-15 |
| Date Mfgr Received | 2008-12-11 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2012-04-10 |
| 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 | 2011-05-26 |
| 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 | N |
| 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 | 2011-05-26 |