MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-18 for ABBOTT REALTIME CT/NG II AMPLIFICATION REAGENT KIT 08L07-91 manufactured by Abbott Molecular, Inc..
[134875375]
Complaint investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
[134875376]
The customer reported that one sample on the abbott ct/ng ii assay run had a "low-grade" positive result. The positive result was reported to the physician. The sample was re-tested, and the result was negative. The molecular application specialist (mas) reviewed the runs from abbottlink. The sample in question has good ic (internal control) amplification in both runs. The amplification curves and reference dye in the run looked as expected. The sample was a swab. In regards to the questioned results reported by the customer, the mas explained to the customer that due to nature of the specimen and behavior of the bacterial dna, the repeat test may not have picked up enough bacteria to have the ct detected. The customer will report the sample as "inconclusive", and they will request a repeat specimen. There was no impact on the patient's health due to the questioned results. Based on the mas review, this report is being processed as a false negative on the realtime ct/ng ii assay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2019-00002 |
| MDR Report Key | 8262246 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-18 |
| Date of Report | 2019-03-06 |
| Date of Event | 2018-12-20 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2018-10-22 |
| Date Added to Maude | 2019-01-18 |
| 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 II AMPLIFICATION REAGENT KIT |
| Generic Name | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA |
| Product Code | MKZ |
| Date Received | 2019-01-18 |
| Catalog Number | 08L07-91 |
| Lot Number | 490156 |
| Device Expiration Date | 2019-09-30 |
| 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 | 2019-01-18 |