MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-24 for APTIMA COMBO 2 ASSAY 301032 manufactured by Gen-probe Incorporated.
[21489822]
A lab tech reported that he splashed specimen in his eye while pipetting reagent prior to performing an in-vitro diagnostic assay for the detection of chlamydia trachomatis and/or neisseria gonorrhoeae. The specimen was in the testing tube, and while adding probe reagent, the specimen splashed into his eye. The lab tech was not wearing goggles as is required by instructions in the package insert for this assay. The lab tech did not know what type of specimen it was, it could be urine or material from a vaginal collection. The lab tech sought medical attention and was given antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[21667224]
Device was not reported to be defective.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024800-2014-00001 |
| MDR Report Key | 3643593 |
| Report Source | 07 |
| Date Received | 2014-02-24 |
| Date of Report | 2014-02-21 |
| Date of Event | 2013-09-23 |
| Date Mfgr Received | 2013-09-23 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-02-25 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. PATRICIA BAKKE |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 921214362 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214362 |
| Manufacturer Phone | 8584108507 |
| Manufacturer G1 | GEN-PROBE, INCORPORATED |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121436 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 4362 |
| 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 | 2014-02-24 |
| Catalog Number | 301032 |
| Lot Number | 633593B |
| Device Expiration Date | 2014-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEN-PROBE INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121870 US 92121 8703 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-24 |