MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-07 for IMMAGE C-REACTIVE PROTEIN REAGENT 447280 manufactured by Beckman Coulter, Inc..
[15441274]
During an internal study at beckman coulter inc. (bci) manufacturing center in carlsbad, it was discovered that image c-reactive protein (crp) reagent lots made with seradyn latex exhibit a hook effect. Further investigation revealed that 4 crp reagent lots are affected (3 released and 1 in-process) and the hook effect is exhibited between 36 and 64 mg/dl, and the reported recovery drops off to approx 3-7mg/dl. No affect to pt treatment or lab personnel was reported as this event was discovered in house and no pt results were reported from this lab.
Patient Sequence No: 1, Text Type: D, B5
[15655980]
Additional lot #s: m709279 and m709319. Add'l expiration dates: 10/31/2009 and 11/30/2009. Add'l mfr dates: 10/29/2007 and 11/15/2007. Bci recently validated a switch from merck latex to seradyn latex. To confirm the finding, 2 merck latex crp lots and all 4 seradyn latex crp lots were used to assay samples that gradually ranged upward from 35 to 65 mg/dl. The 4 seradyn lots begin to hook down to approx 3-7 mg/dl somewhere between 36-65mg/dl. Both merck lots recovered correct values for all samples up through 65 mg/dl. In addition, it was noted that crp reagent with seradyn latex lot number 1450 hooks at a much lower level than does crp reagent with seradyn latex lot number 112161. Crp reagent is intended for the quantitative determination of crp in human serum or plasma by rate nephelometry and the measurement aids in evaluation of stress, trauma, infection, inflammation, and surgery. A capa has been opened to determine the root cause of the issue. Bci will initiate a product corrective action (pca) regarding this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2008-00001 |
| MDR Report Key | 976703 |
| Report Source | 05 |
| Date Received | 2008-01-07 |
| Date of Report | 2008-01-08 |
| Date of Event | 2007-12-12 |
| Date Mfgr Received | 2007-12-12 |
| Device Manufacturer Date | 2007-09-17 |
| Date Added to Maude | 2008-09-29 |
| 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 | ANNE SABER, PHD, DIRECTOR |
| Manufacturer Street | 11800 SW 147TH AVE MAILSTOP 31-B06 |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal | 33196 |
| Manufacturer Phone | 3053802618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE C-REACTIVE PROTEIN REAGENT |
| Generic Name | NA |
| Product Code | DCK |
| Date Received | 2008-01-07 |
| Model Number | NA |
| Catalog Number | 447280 |
| Lot Number | M705441 |
| Device Expiration Date | 2009-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 985862 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 200 SOUTH KRAEMER BLVD. BREA CA 92822 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-07 |