MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-17 for APTIMA COMBO 2 ASSAY 301040-01 manufactured by Hologic Incorporated.
[5093594]
The lab tech reported that she splashed solution contained in the aptima combo 2 urine specimen collection tube into her eyes. As she was pipetting the urine into the specimen collection tube with the provided pipet, the transport media raised and bubbled up and a bubble popped close to her face. It was noted that she is short in stature and therefore was close to the tube. The lab tech was not wearing goggles as is required by instruction in the package insert for the aptima combo 2 urine specimen collection kit, but was wearing gloves and a lab coat. After the event, the lab tech flushed her eyes with water and went to the er and was prescribed antibiotics. According to the safety data sheet for the aptima combo 2 urine specimen collection kit, the solution is not considered hazardous by the 2012 osha hazard communication standard (29 cfr 1910. 1200).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2014-00003 |
| MDR Report Key | 4182416 |
| Report Source | 07 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-09-18 |
| Date Mfgr Received | 2014-09-18 |
| Device Manufacturer Date | 2014-04-30 |
| Date Added to Maude | 2014-10-20 |
| 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 | MR. RON DOMINGO |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108167 |
| Manufacturer G1 | HOLOGIC INCORPORATED |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92129 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92129 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTIMA COMBO 2 ASSAY |
| Generic Name | IN-VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2014-10-17 |
| Catalog Number | 301040-01 |
| Lot Number | 108724A |
| Device Expiration Date | 2015-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-17 |