MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-10 for ABBOTT REALTIME CMV AMPLIFICATION REAGENT 09N21- 090 manufactured by Abbott Molecular, Inc..
[133958130]
Complaint investigation will be performed. Note: lot, expiration, udi, manufacture date and pma number have been left blank as this mdr is being submitted on the basis that realtime cmv amplification reagent kit (list number 05n23-90) is similar to us fda approved realtime cmv amplification reagent kit (list number 09n21-090). Ticket does not reference a us list 09n21-090 lot number.
Patient Sequence No: 1, Text Type: N, H10
[133958131]
The customer reported a viral load of 4831 copies/ml on the abbott realtime cmv assay. The clinician requested resistance genotyping for the patient sample in question because the results did not match patient history. The patient is a lung transplant patient under antiviral treatment. However at the resistance testing laboratory, a viral load of 125 iu/ml was detected and sequencing testing could not be performed due to the minimum viral load for sequencing is set to 500 iu/ml in the resistance testing laboratory. Customer also reported that one week later, the same sample was run again and 212 copies/ml was reported. The clinical physician questioned the results, and therefore they did not change the patient treatment. There was no impact to patient health as a result of the results in question. This incident is being reported to fda because the incident occurred in france using the realtime cmv amplification reagent kit, list number 05n23-90 which is same/similar to us fda approved realtime cmv amplification reagent kit, list number 09n21-090.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2019-00001 |
| MDR Report Key | 8237302 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-10 |
| Date of Report | 2019-02-27 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2019-02-22 |
| Date Added to Maude | 2019-01-10 |
| 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 CMV AMPLIFICATION REAGENT |
| Generic Name | CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY |
| Product Code | PAB |
| Date Received | 2019-01-10 |
| Catalog Number | 09N21- 090 |
| 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 | 2019-01-10 |