MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-16 for ACTIVE? INHIBIN A ELISA, 96 WELLS DSL-10-28100-1 manufactured by Beckman Coulter Inc..
[1441496]
A customer reported to beckman coulter inc. , (bci) that three patient samples gave higher than expected results using the dsl inhibin a methodology. The results are discordant to the oxford-bioinnovation inhibin assay which gave negative results. Based on available information, patients underwent further diagnostic testing.
Patient Sequence No: 1, Text Type: D, B5
[8489814]
Patient samples were sent to customer product line support (cpls) for further testing. Cpls confirmed the results were due to heterophile interference. Per product labeling, the assay is not validated for use to determine gonadal maturity in children. For assays employing antibodies, the possibility exists for interference by heterophile antibodies in the patient sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628193-2010-00001 |
| MDR Report Key | 1632767 |
| Report Source | 05 |
| Date Received | 2010-03-16 |
| Date of Report | 2010-03-16 |
| Date of Event | 2010-02-17 |
| Date Mfgr Received | 2010-02-17 |
| Date Added to Maude | 2010-03-17 |
| 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 BLVD. |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVE? INHIBIN A ELISA, 96 WELLS |
| Generic Name | INHIBIN A ENZYME-LINKED IMMUNOSORBENT (ELISA) |
| Product Code | NDR |
| Date Received | 2010-03-16 |
| Model Number | NA |
| Catalog Number | DSL-10-28100-1 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2010-03-16 |