MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-23 for SERACLONE ANTI-K (KEL1) 808 090 100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2157538]
The customer reported false negative reactions of seraclone anti-k with a kell heterozygous cell from reagent red blood cells of a competitor. The customer had sent us the allegedly defective sample and the affected competitor's reagent red blood cells. Both were rested and reacted correctly positive. The allegedly defective sample was tested with further k+k+ red cells of donors and commercially available panel cells. All positive reactions were correct and unambiguous positive. We did not observe any false negative reactions. Testing of our quality control laboratory confirmed the correct function of the affected lot of seraclone anti-k. A review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained product.
Patient Sequence No: 1, Text Type: D, B5
[9393185]
Stn# 125230.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00113 |
| MDR Report Key | 2254818 |
| Report Source | 05 |
| Date Received | 2011-08-23 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-07-22 |
| Date Mfgr Received | 2011-07-22 |
| Date Added to Maude | 2012-05-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. MARC GORZELLIK |
| Manufacturer Street | INDUSTRIESTRASSE 1 |
| Manufacturer City | DREIEICH 63303 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63303 |
| Manufacturer Phone | 103801528 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERACLONE ANTI-K (KEL1) |
| Generic Name | SERACLONE ANTI-K |
| Product Code | LKJ |
| Date Received | 2011-08-23 |
| Returned To Mfg | 2011-08-03 |
| Catalog Number | 808 090 100 |
| Lot Number | 7007130-01 |
| Device Expiration Date | 2011-08-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-23 |