MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-07-13 for ACCESS FOLATE ASSAY A14207 manufactured by Beckman Coulter, Inc..
[16046007]
Beckman coulter inc. Internal investigation results indicated that three commercially released access folate assay calibrator lots recovered higher than comparable beckman coulter inc. Reference calibrator values. These lots simulated stability results equaled or exceeded upper stability acceptance limits as well. Through beckman coulter inc. Internal investigation, it was also identified that a fourth commercially released access folate assay calibrator lot, from a second beckman coulter inc. Product code, did not satisfy specific product stability time point the two access folate assay calibrator product codes involved with this event possessed identical formulations. This report represents the elevated dose recovery and simulated stability results experienced by one of the access folate assay calibrator product codes, a14207, with lot number 112788. An evaluation of internal assessment data revealed that this lot's recovering dose was approximately eighteen percent higher than internal folate reference calibrators. Further investigation also indicated that access folate assay calibrator lot 112788 simulated stability results were projected to exceed the stability testing requirements of twelve percent. No patient results were involved in this specific event and hence there was no death, serious injury or modification to patient treatment associated or attributed to this event.
Patient Sequence No: 1, Text Type: D, B5
[16242833]
This issue is currently being investigated by beckman coulter inc. Device evaluation was performed as part of initial event investigation and is ongoing as part of further investigative activities. The cause of this event is currently unknown. Correction/corrective action is ongoing. (b)(4). Mdrs associated with this event: 2122870-2012-01600, 2122870-2012-01607, 2122870-2012-01608, 2122870-2012-01609.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2012-01600 |
| MDR Report Key | 2655423 |
| Report Source | 00 |
| Date Received | 2012-07-13 |
| Date of Report | 2012-06-19 |
| Date of Event | 2012-06-19 |
| Date Mfgr Received | 2012-06-19 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-10-19 |
| 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 | 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS FOLATE ASSAY |
| Generic Name | ACID, FOLIC, RADIOIMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2012-07-13 |
| Model Number | NA |
| Catalog Number | A14207 |
| Lot Number | 112788 |
| ID Number | NA |
| Device Expiration Date | 2012-06-30 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-13 |