MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for LIQUICHEK DIABETES CONTROL LEVEL 1 171 manufactured by Bio-rad Laboratories Inc.
[121864315]
The labeling for liquichek diabetes control indicates this product is manufactured from human source material components. The labeling has a warning statement and a caution symbol indicating the product contains human source material and must be treated as potentially infectious. Each human donor unit used to manufacture this product was tested as required by fda accepted methods. Tests results were non-reactive or negative for evidence of infection due to human immunodeficiency virus (hiv), hepatitis b virus (hbv) and hepatitis c virus (hcv). This product may also contain other human source materials for which there are no approved tests. In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.
Patient Sequence No: 1, Text Type: N, H10
[121864318]
On september 06, 2018, bio-rad qsd, (b)(4) received a report for a potential adverse event where a laboratory technician splashed liquichek diabetes control lot # 38560 into her eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2018-00004 |
| MDR Report Key | 7906291 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2017-02-28 |
| Date Added to Maude | 2018-09-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARIA ZEBALLOS |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIQUICHEK DIABETES CONTROL LEVEL 1 |
| Generic Name | HEMOGLOBIN CONTROL |
| Product Code | GGM |
| Date Received | 2018-09-25 |
| Catalog Number | 171 |
| Lot Number | 38561 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES INC |
| Manufacturer Address | 9500 JERONIMO ROAD IRVINE CA 926182017 US 926182017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-25 |