MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-23 for METER TRAX CONTROL 973 manufactured by Bio-rad Laboratories.
[20415295]
A lab employee cut her finger on a broken hematocrit that contained meter trax control level high.
Patient Sequence No: 1, Text Type: D, B5
[20579994]
The labeling and certificate of analysis of the control material indicate that each human whole blood donor unit used manufacture this control was tested by fda- accepted methods and found (b)(6) for (b)(6), antibody to (b)(6), and antibody to (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 | 2016706-2011-00001 |
| MDR Report Key | 2011788 |
| Report Source | 07 |
| Date Received | 2011-02-23 |
| Date of Report | 2011-02-10 |
| Date of Event | 2011-01-28 |
| Date Mfgr Received | 2011-01-28 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2012-05-22 |
| 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 | 19 TECHNOLOGY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981285 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METER TRAX CONTROL |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJT |
| Date Received | 2011-02-23 |
| Model Number | NA |
| Catalog Number | 973 |
| Lot Number | 92373 |
| ID Number | NA |
| Device Expiration Date | 2011-04-11 |
| 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-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-23 |