MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-13 for ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT 8L07-91 manufactured by Abbott Molecular, Inc..
[117435719]
Complaint investigation will be performed. Customer ran swab sample a third time, which is outside the package insert instructions that state samples can be run two times. Customer added water to the sample to ensure enough volume; there are no instructions within the package insert for dilution of samples. Note: lot, expiration, udi, manufacture date and pma number have been left blank as this mdr is being submitted on the basis that abbott realtime (b)(6) amplification reagent kit (2g28-91) is similar to the abbott realtime (b)(6) 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
[117435720]
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 called to question a negative (b)(6) result received for one sample of a realtime (b)(6) run. Results of the first run were (b)(6) = beyond cutoff and (b)(6) = (b)(6); therefore per package insert instructions for beyond cutoff (b)(6) samples, the sample was repeated. In the second run, the results were (b)(6) = (b)(6) and (b)(6) = (b)(6), but the customer is not confident on the (b)(6) result because the amplification curve is coming up later in the run. The sample type was a swab taken with the abbott multicollect kit. Customer reported that the sample in question was tested a third time and the result generated was (b)(6) for (b)(6). As the sample volume for this third retest was not sufficient, the customer added 1ml of water to bring the remaining sample up to necessary volume for running on the (b)(4) instrument. Abbott realtime (b)(6) assay package insert, 51-608203/r3 contains no instructions for dilution of samples. When asked customer states they are confident no contamination took place after first running the sample. Patient history shows patient as (b)(6) for both (b)(6) and (b)(6) in may, in june it was (b)(6) for both. The expected result for july was (b)(6) as (b)(6) symptoms had disappeared. Patient was being tested for check-up. After testing (b)(6) in june patient received antibiotic doxycycline. Final result that was reported to the physician was (b)(6) for (b)(6) and (b)(6), in consistency with patient history. This incident is being reported to fda because the incident occurred in (b)(6) using realtime (b)(6) list number 2g28-91 which is same/similar to us fda approved realtime (b)(6) list number 8l07-91.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2018-00009 |
| MDR Report Key | 7779244 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-13 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-08-13 |
| 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 | 3 |
| Brand Name | ABBOTT REALTIME CT/NG AMPLIFICATION REAGENT KIT |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2018-08-13 |
| Catalog Number | 8L07-91 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-13 |