MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-04-08 for LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL 274 manufactured by Bio-rad Laboratories.
[14929643]
A laboratory employee splashed lypochek whole blood immunosuppressant control level 1 into her eyes while opening an ampoule of the control.
Patient Sequence No: 1, Text Type: D, B5
[15497018]
The labeling and certificate of analysis indicate that each human donor unit used to mfr the product was "tested and found (b)(6) for (b)(6), antibody to (b)(6), and (b)(6). " in addition, the labeling instructs the users to treat all human source material as potentially infectious and should be handled with the same precautions used with pt specimens. The root cause of the event was user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016706-2011-00002 |
| MDR Report Key | 2089785 |
| Report Source | 07 |
| Date Received | 2011-04-08 |
| Date of Report | 2011-04-07 |
| Date of Event | 2011-04-01 |
| Date Mfgr Received | 2011-04-01 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2012-06-05 |
| 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 | JANICE JOHNSON |
| Manufacturer Street | 19 TECHNOLOGY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981445 |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL |
| Generic Name | REFER TO 510 (K) |
| Product Code | DIF |
| Date Received | 2011-04-08 |
| Model Number | NA |
| Catalog Number | 274 |
| Lot Number | 11830 |
| ID Number | NA |
| Device Expiration Date | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-04-08 |