MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-07 for ACTIVE? IGF-BP3 RIA DSL-6600 manufactured by Beckman Coulter Inc..
[1498366]
A customer reported to beckman coulter inc. , (bci) that samples gave higher than expected results using the dsl igf-bp3 methodology. The results are discordant to the normal values described in the kit insert and igf-1 status. The results were reported outside of the lab. Patients underwent further diagnostic testing.
Patient Sequence No: 1, Text Type: D, B5
[8566699]
A clear root cause for this event has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628193-2010-00002 |
| MDR Report Key | 1677583 |
| Report Source | 05 |
| Date Received | 2010-05-07 |
| Date of Report | 2010-05-07 |
| Date of Event | 2010-02-10 |
| Date Mfgr Received | 2010-02-12 |
| Date Added to Maude | 2011-12-23 |
| 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 | 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? IGF-BP3 RIA |
| Generic Name | INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3 |
| Product Code | CFL |
| Date Received | 2010-05-07 |
| Model Number | NA |
| Catalog Number | DSL-6600 |
| Lot Number | 100115 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2010-05-07 |