MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-08 for LYPHOCHEK IMMUNOASSAY PLUS CONTROL 371 manufactured by Bio-rad Laboratories.
[37724411]
The labeling for lyphochek immunoassay plus control indicates that each human donor unit used to manufacture this control was "tested by fda accepted methods and found (b)(6). In addition, the labeling for lyphochek immunoassay plus control instructs the users to treat all human source material as potentially infectious and should be handled with the same precautions used with patient specimens.
Patient Sequence No: 1, Text Type: N, H10
[37724412]
Customer was opening a glass vial of the quality control when a piece of broken glass cutting her right thumb.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2016-00001 |
| MDR Report Key | 5417986 |
| Date Received | 2016-02-08 |
| Date of Report | 2016-02-07 |
| Date of Event | 2016-01-07 |
| Date Mfgr Received | 2016-01-08 |
| Device Manufacturer Date | 2014-08-30 |
| Date Added to Maude | 2016-02-08 |
| 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 | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ELIZABETH PLATT |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981265 |
| Manufacturer G1 | BIO-RAD LABORATORIES |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 926182017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LYPHOCHEK IMMUNOASSAY PLUS CONTROL |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJY |
| Date Received | 2016-02-08 |
| Returned To Mfg | 2016-01-26 |
| Catalog Number | 371 |
| Lot Number | 40311 |
| Device Expiration Date | 2017-12-31 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO ROAD IRVINE CA 926182017 US 926182017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-08 |