MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-30 for MAS CHEMTRAK H CHU-1 manufactured by Microgenics Corp..
[21317930]
A laboratory tech at (b)(6) hosp located at (b)(6) reported cutting their finger on a vial broken during handling. The laboratory tech was wearing gloves at the time of the incident, no sutures were required. The cause of the vial breakage is undetermined. The complaint also reported that the laboratory tested the remaining vial contents using vitros 5600 and obtained results (b)(6) for (b)(6). The customer generated (b)(6) results when performing secondary testing using the (b)(6) test. Lab tech began preventative medical treatment for (b)(6). Manufacturer testing was completed on july 08 for the retained samples as well as returned unused product from the customer. Testing occurred at (b)(4), an affiliate of thermofisher scientific, on the abbott architect (b)(6) assay and the procleix ultrio combo system. The results displayed no (b)(6) for (b)(6) from both systems. The customer sent the product for western blot testing with (b)(6) results for (b)(6) on all bands. The date for the testing is unk. No product malfunction has been asserted or identified.
Patient Sequence No: 1, Text Type: D, B5
[21576472]
(b)(4) selected as pt has not reported infection with (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937369-2014-00001 |
| MDR Report Key | 3999216 |
| Report Source | 05 |
| Date Received | 2014-07-30 |
| Date of Report | 2014-07-29 |
| Date of Event | 2014-06-30 |
| Date Mfgr Received | 2014-06-30 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2014-08-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVE WURTZ |
| Manufacturer Street | 46360 FREMONT BLVD |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5109795169 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAS CHEMTRAK H |
| Generic Name | CHEMTRAK H LIQUID ASSAYED CHEM CNTRL |
| Product Code | JJY |
| Date Received | 2014-07-30 |
| Model Number | NA |
| Catalog Number | CHU-1 |
| Lot Number | CHU14081 |
| ID Number | NA |
| Device Expiration Date | 2014-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROGENICS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-30 |