MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-31 for LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT 146 manufactured by Bio-radd, Laboratories.
[1082636]
A lab professional splashed control material in her eye. She was trying to remove bubbles from an instrument cuvette when the pipette tip 'caught' and flicked the control material in her eye. There was no immediate harm to the lab professional.
Patient Sequence No: 1, Text Type: D, B5
[8226159]
The labeling and certificate of analysis of the control material indicate that each human donor unit used to manufacture this control was tested by fda-accepted methods and found non-reactive for (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. Root cause of event: user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016706-2009-00001 |
| MDR Report Key | 1353990 |
| Report Source | 07 |
| Date Received | 2009-03-31 |
| Date of Report | 2009-03-26 |
| Date of Event | 2009-03-05 |
| Date Mfgr Received | 2009-03-05 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2010-08-21 |
| 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 | 0 |
| Manufacturer Contact | JANICE JOHNSON, REP |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981445 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT |
| Generic Name | QUALITY CONTROL (ASSAYED AND UNASSAYED) |
| Product Code | JJT |
| Date Received | 2009-03-31 |
| Model Number | NA |
| Catalog Number | 146 |
| Lot Number | 23450 |
| Device Expiration Date | 2011-04-30 |
| 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-RADD, LABORATORIES |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-31 |