MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-06-01 for ACTIVE? INHIBIN A ELISA, 4X96 WELLS N/A DSL-10-28100-4 manufactured by Beckman Coulter Inc..
[22093020]
A customer contacted beckman coulter inc. (bci) to report observing higher than expected dsl inhibin a manual elisa methodology results for one sample. Per customer's sop all results which do not fit the clinical picture of a patient is retested. The samples were repeated on (b)(6) 2010. Subsequent analysis was performed utilizing hbr blocking tubes which resulted in lower dose recovery. The customer indicated that the lower dose recovery of immeasurable inhibin a obtained post hbr blocking tubes analysis was expected based on the patients' clinical picture. The results were not reported out of the laboratory. The customer did not receive any report of patient injury requiring medical intervention or change to patient treatment attributed or connected with this event.
Patient Sequence No: 1, Text Type: D, B5
[22256898]
Samples collection and centrifugation data was not supplied. Samples storage including conditions for time frame between initial testing and subsequent hbr blocking analysis was not provided. Calibration curves parameters and qc data was not supplied. Per customer, the assays were performed on a manual elisa assay platform. Specific equipment maintenance records were not supplied. Service was not dispatched. A heterophile interference phenomenon was not confirmed by bci for this event. A definitive root cause has not been determined to date for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-01623 |
| MDR Report Key | 2110689 |
| Report Source | 01,05 |
| Date Received | 2011-06-01 |
| Date of Report | 2011-04-28 |
| Date of Event | 2010-09-20 |
| Date Mfgr Received | 2011-04-28 |
| Device Manufacturer Date | 2010-10-19 |
| Date Added to Maude | 2012-04-12 |
| 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 | 3 |
| 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 DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| 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 | 2011-06-01 |
| Model Number | N/A |
| Catalog Number | DSL-10-28100-4 |
| Lot Number | 090498, 091055, 090798 |
| ID Number | N/A |
| 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 | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-01 |