MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT 8L07-91 manufactured by Abbott Molecular, Inc..
[112141219]
Complaint investigation will be performed. Lot, expiration, udi, manufacture date and pma number have been left blank as this mdr is being submitted on the basis that abbott realtime ct/ng amplification reagent kit (2g28-91) is similar to the abbott realtime ct/ng amplification reagent kit (8l07-91) sold in the united states. Ticket does not reference a us list 8l07-91 lot number.
Patient Sequence No: 1, Text Type: N, H10
[112141220]
The abbott realtime ct/ng assay is an in vitro polymerase chain reaction (pcr) assay for the direct, qualitative detection of the plasmid dna for (b)(6) and the genomic dna of (b)(6) in female endocervical or vaginal swab specimens, male urethral swab specimens, or in male and female urine specimens. Customer informed abbott that during handling of patient sample (urine) inside a multi-collect specimen collection tube, the sample splashed into the customer's eye. The customer did not wear protective goggles. Customer was instructed as per latest material safety data sheet to rinse the eye with an eye shower and to inform a doctor. Customer washed the eye with the eye shower for 10-20 minutes. Eye was irritated and red. The customer received antibiotic treatment as it was not known at that time, if the sample was (b)(6). Patient sample was tested and was determined to be (b)(6) for both (b)(6) and (b)(6). Customer fully recovered. This incident is being reported to fda because the incident occurred in (b)(6) using realtime ct/ng list number 2g28-91 which is same/ similar to us fda approved realtime ct/ng list number 8l07-91.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2018-00006 |
| MDR Report Key | 7631723 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-06-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JOE HUTSON |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617619 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2018-06-22 |
| Catalog Number | 8L07-91 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-22 |