MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-24 for LIQUICHEK SPINAL FLUID CONTROL LEVEL 1 751 manufactured by Bio-rad Laboratories Inc.
[90953373]
Bio-rad sent samples of liquichek spinal fluid lot 55660 to two different labs using two different test methods (hologic procleix grifols nat and roche mpx v2. 0 multiplex nat) to analyze for (b)(6). Results were reported as (b)(6). Bio-rad also reviewed the vendor certificate of analysis (coa) for all human sourced raw materials used. The raw materials indicted (b)(6) results for (b)(6) using fda approved methods.
Patient Sequence No: 1, Text Type: N, H10
[90953374]
On october 10, 2017 bio-rad (b)(4) received a report from the university (b)(6) in the (b)(6) of an eye splash involving liquichek spinal fluid control that had occurred approximately 4 weeks earlier. A lab technician had splashed the spinal fluid control into her eye. She had recently developed a "rash and temperature rise consistent with (b)(6)".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2017-00003 |
| MDR Report Key | 6974280 |
| Date Received | 2017-10-24 |
| Date of Event | 2017-09-10 |
| Date Mfgr Received | 2017-10-10 |
| Date Added to Maude | 2017-10-24 |
| 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 | DR SUZANNE PARSONS |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIQUICHEK SPINAL FLUID CONTROL LEVEL 1 |
| Generic Name | MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) |
| Product Code | JJY |
| Date Received | 2017-10-24 |
| Catalog Number | 751 |
| Lot Number | 55661 |
| Device Expiration Date | 2018-06-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-24 |