MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-04-07 for ACTIVE? INHIBIN A ELISA, 4X96 WELLS DSL-10-28100-4 manufactured by Beckman Coulter Inc..
[1855345]
A customer contacted beckman coulter inc (bci) stating that the data generated during lot to lot correlations for the active inhibin a elisa methodology did not meet the laboratory's expectation criteria. The customer indicated that the lot is exhibiting a positive bias when compared to older lot samples recoveries. Customer indicated comparison data did not meet own comparison data expectation criteria with patient samples demonstrating an average increase of 23% across five (5) samples when using the new reagent lot compared to an older lot. The customer also indicated that the comparison assay analysis was performed on multiple days and not a true side by side analysis. The studies did not include any patient samples that were used for reporting. The customer did not report affect to the patient or user attributed or connected to this event.
Patient Sequence No: 1, Text Type: D, B5
[9178005]
Sample collection and centrifugation data was not supplied. Sample storage including conditions for time frame between lot correlation evaluations was not supplied. Assays were performed on a manual elisa assay platform. Qc data points identified that the qc recovery was within the established ranges. Customer's internal pool control (mms) recoveries are outside laboratory's established range high in all the assay runs supplied. Symptom reported is relative to customer's expectations of % difference between lots which was not related. Internal investigation is pending to date, and no clear root cause has been determined thus far.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-00913 |
| MDR Report Key | 2042778 |
| Report Source | 06 |
| Date Received | 2011-04-07 |
| Date of Report | 2011-03-01 |
| Date of Event | 2011-03-01 |
| Date Mfgr Received | 2011-03-01 |
| Date Added to Maude | 2011-10-05 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 445 WEST MEDICAL CENTER BLVD. |
| Manufacturer City | WEBSTER TX 77598 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77598 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-03/31/2011-014C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVE? INHIBIN A ELISA, 4X96 WELLS |
| Generic Name | INHIBIN A ENZYME-LINKED IMMUNOSORBENT (ELISA) |
| Product Code | NDR |
| Date Received | 2011-04-07 |
| Model Number | NA |
| Catalog Number | DSL-10-28100-4 |
| Lot Number | 091078 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 445 WEST MEDICAL CENTER BLVD. WEBSTER TX 77598 US 77598 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-07 |