MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-18 for LYPOCHEK DIABETES CONTROL 740 manufactured by .
[5295464]
A laboratory employee was pippeting lyphochek diabetes control. While discarding a pipet tip containing the control, the tip bounced off the side of the biohazard waste container and hit the laboratory employee in the corner of her right eye. The laboratory employee removed her contact lens, irrigated her eye and sought medical attention.
Patient Sequence No: 1, Text Type: D, B5
[12594799]
The labeling and certificate of analysis for lypochek diabetes control indicates that each human whole blood donor unit used to manufacture the product was tested by fda acceptable methods and found non-reactive for (b)(6) surface antigen (b)(6), antibody to (b)(6) and antibody to (b)(6). In addition, the manual instructs the users to treat all human source material as potentially infectious and should be handled with the same precautions use with patient specimens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016706-2014-00003 |
| MDR Report Key | 4276165 |
| Report Source | 07 |
| Date Received | 2014-11-18 |
| Date of Report | 2014-11-17 |
| Date of Event | 2014-10-23 |
| Date Mfgr Received | 2014-10-23 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-11-26 |
| 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 | ELIZABETH PLATT |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981285 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYPOCHEK DIABETES CONTROL |
| Product Code | GGM |
| Date Received | 2014-11-18 |
| Model Number | NA |
| Catalog Number | 740 |
| Lot Number | 33881 |
| ID Number | (01)00847661002185 |
| Device Expiration Date | 2016-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-18 |